Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001882367 Date of Approval: 21/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mucuna pruriens in Parkinson disease: an international clinical trial
Official scientific title Mucuna pruriens in Parkinson disease: an international multicentre, non-inferiority, randomised, controlled clinical trial
Brief summary describing the background and objectives of the trial Background. Hundrends of thousands of individuals with Parkinson's disease (PD) in low-income countries worldwide remain either undertreated or untreated due to unavailability and/or unaffordability of long-term levodopa therapy. Mucuna pruriens (MP) is a leguminous plant growing in all tropical areas worldwide, whose seeds contain high concentrations of levodopa. General Aim. In this international multicentre, randomised, controlled study, we aim to demonstrate the non-inferiority of long-term intake of Mucuna powder (in terms of efficacy and safety) compared to standard therapy with Levodopa+Benserazide tablets. Methodology. A total of 90 patients with PD will be enrolled in the multicentre study (of these, n=20 will be recruited at the KBTH and n=10 at the Comboni Hospital). Patients will be randomised in 1:1 ratio to receive the either (1) levodopa/benserazide 200+50mg oral tablets, or (2) MP powder (obtained directly from roasted seeds without any pharmacological processing). Primary endpoint is the non-inferiority of MP in the summary index of a questionnaire on quality of life (the 39-item Parkinson¿s Disease Questionnaire, PDQ-39). Safety measures include overall tolerability and any adverse event. Expected Outcome. We expect that the intake of MP powder will be non-inferior to marketed levodopa preparations in terms of both efficacy and safety. We hope that these results will conclusively demonstrate that MP is a safe and effective alternative source of levodopa to treat individuals with PD who cannot afford long-term therapy with marketed pharmaceutical levodopa preparations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Parkinsons Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/06/2017
Actual trial start date 29/01/2018
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date 08/02/2021
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 35
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Updates updates
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised computer generated randomization list (permuted-block randomization with varying block sizes) Concealment will be attained by using sealed envelopes. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MP group 10 grams three-to-four times daily 12 months Mucuna pruriens powder from roasted seeds 35
Control Group Levodopa/Benserazide 200+50mg half tab up to four times daily 12 months Control group using the reference treatment 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) diagnosis of idiopathic PD according to UK Brain Bank criteria (Hughes et al., 1992); (b) newly diagnosed PD within the past 2 years; (c) never treated with levodopa or treated for ¿6 months during the disease course but levodopa discontinued since at least 3 months; (d) age ¿30 years. (i) signs of cognitive impairment (according to DSM-IV-TR criteria or MMSE<26) limiting the availability for a written informed consent; (ii) clinically significant psychiatric illness (e.g. severe depression or psychosis); (iii) Hoehn and Yahr stage 5/5; (iv) severe, unstable medical conditions (e.g. neoplasms; unstable diabetes mellitus; heart, renal or liver failure); (v) pregnancy. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 80 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/01/2017 Korle Bu Teaching Hospital Scientific and Techincal Committee
Ethics Committee Address
Street address City Postal code Country
Guggisberg Ave Accra P.O. Box 7 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2017 CHRPE
Ethics Committee Address
Street address City Postal code Country
Accra Rd, Kumasi, Ghana Kumasi Universit Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Summary index of the 39-item Parkinson¿s Disease Questionnaire (PDQ-39) quality-of-life scale (Jankinson et al., 1997) Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
Secondary Outcome (b) number of patients withdrawn from the study or lost to follow up Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
Secondary Outcome (a) the patient-rated functional status on the mobility subscale of the PDQ-39 and other domains such as compliance Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
Secondary Outcome (c) dyskinesias, measured with items 32 to 35 of the UPDRS part IV Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
Secondary Outcome (d) levodopa-induced motor response fluctuations throughout the course of the study measured with items 36 to 39 of the UPDRS part IV Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
Secondary Outcome (e) any adverse events defined as the frequency, severity, nature, and duration of any adverse event throughout the course of the study Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
Secondary Outcome (f) working status and absence from paid and (g) resource utilisation outside of the participating hospitals work, measured with a standardised questionnaires (Verschuur et al., 2015) Baseline; 1-month; 3-month; 6-month; 9-month; 12-month (end-of-study)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Comboni Hospital Adela Akalo Street Sogakope P.O. Box SK 95 Ghana
Komfo Anokye Teaching Hospital Okomfo Anokye Road Kumasi P.O.Box 1934 Ghana
Korle Bu Teaching Hospital Guggisberg Ave Accra P. O. Box 77 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Fondazione Grigioni per il Morbo di Parkinson via Zuretti 35 Milan 20125 Italy
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fondazione Grigioni per il Morbo di Parkinson via Zuretti 35 Milan 20125 Italy Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Roberto Cilia via Cleoria 11 Milan 20133 Italy
Albert Akpalu Guggisberg Ave Accra P. O. Box 77 Ghana
Momodou Cham Comboni Hospital Sogakope P.O. Box 100 Ghana
Fred Stephen Sarfo Okomfo Anokye Road Kumasi P.O.Box 1934 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roberto Cilia roberto.cilia@gmail.com +390223942368 Via Celoria 11
City Postal code Country Position/Affiliation
Milano 20133 Italy Consultant Neurologist
Role Name Email Phone Street address
Public Enquiries Roberto Cilia roberto.cilia@gmail.com +390223952368 via Celoria 11
City Postal code Country Position/Affiliation
Milano 20133 Italy Consultant Neurologist
Role Name Email Phone Street address
Scientific Enquiries Roberto Cilia roberto.cilia@gmail.com +390223942368 via Celoria 11
City Postal code Country Position/Affiliation
Milano 20126 Italy Consultant Neurologist
Role Name Email Phone Street address
Principal Investigator Roberto Cilia roberto.cilia@gmail.com +390223942368 Via Celoria 11
City Postal code Country Position/Affiliation
Milano 20133 Italy Consultant Neurologist
Role Name Email Phone Street address
Public Enquiries Roberto Cilia roberto.cilia@gmail.com +390223952368 via Celoria 11
City Postal code Country Position/Affiliation
Milano 20133 Italy Consultant Neurologist
Role Name Email Phone Street address
Scientific Enquiries Roberto Cilia roberto.cilia@gmail.com +390223942368 via Celoria 11
City Postal code Country Position/Affiliation
Milano 20126 Italy Consultant Neurologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Informed Consent Form,Statistical Analysis Plan,Study Protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/05/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 21/11/2016 typo Mucuna pruriens in Parkinson¿s disease: an international clinical trial Mucuna pruriens in Parkinson's disease: an international clinical trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 21/11/2016 typo Mucuna pruriens in Parkinson¿s disease: an international clinical trial Mucuna pruriens in Parkinson disease: an international clinical trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 21/11/2016 typo Mucuna pruriens in Parkinson¿s disease: an international multicentre, non-inferiority, randomised, controlled clinical trial Mucuna pruriens in Parkinson disease: an international multicentre, non-inferiority, randomised, controlled clinical trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 30/04/2025 No change Background. Hundrends of thousands of individuals with Parkinson¿s disease (PD) in low-income countries worldwide remain either undertreated or untreated due to unavailability and/or unaffordability of long-term levodopa therapy. Mucuna pruriens (MP) is a leguminous plant growing in all tropical areas worldwide, whose seeds contain high concentrations of levodopa. General Aim. In this international multicentre, randomised, controlled study, we aim to demonstrate the non-inferiority of long-term intake of Mucuna powder (in terms of efficacy and safety) compared to standard therapy with Levodopa+Benserazide tablets. Methodology. A total of 90 patients with PD will be enrolled in the multicentre study (of these, n=20 will be recruited at the KBTH and n=10 at the Comboni Hospital). Patients will be randomised in 1:1 ratio to receive the either (1) levodopa/benserazide 200+50mg oral tablets, or (2) MP powder (obtained directly from roasted seeds without any pharmacological processing). Primary endpoint is the non-inferiority of MP in the summary index of a questionnaire on quality of life (the 39-item Parkinson¿s Disease Questionnaire, PDQ-39). Safety measures include overall tolerability and any adverse event. Expected Outcome. We expect that the intake of MP powder will be non-inferior to marketed levodopa preparations in terms of both efficacy and safety. We hope that these results will conclusively demonstrate that MP is a safe and effective alternative source of levodopa to treat individuals with PD who cannot afford long-term therapy with marketed pharmaceutical levodopa preparations. Background. Hundrends of thousands of individuals with Parkinson's disease (PD) in low-income countries worldwide remain either undertreated or untreated due to unavailability and/or unaffordability of long-term levodopa therapy. Mucuna pruriens (MP) is a leguminous plant growing in all tropical areas worldwide, whose seeds contain high concentrations of levodopa. General Aim. In this international multicentre, randomised, controlled study, we aim to demonstrate the non-inferiority of long-term intake of Mucuna powder (in terms of efficacy and safety) compared to standard therapy with Levodopa+Benserazide tablets. Methodology. A total of 90 patients with PD will be enrolled in the multicentre study (of these, n=20 will be recruited at the KBTH and n=10 at the Comboni Hospital). Patients will be randomised in 1:1 ratio to receive the either (1) levodopa/benserazide 200+50mg oral tablets, or (2) MP powder (obtained directly from roasted seeds without any pharmacological processing). Primary endpoint is the non-inferiority of MP in the summary index of a questionnaire on quality of life (the 39-item Parkinson¿s Disease Questionnaire, PDQ-39). Safety measures include overall tolerability and any adverse event. Expected Outcome. We expect that the intake of MP powder will be non-inferior to marketed levodopa preparations in terms of both efficacy and safety. We hope that these results will conclusively demonstrate that MP is a safe and effective alternative source of levodopa to treat individuals with PD who cannot afford long-term therapy with marketed pharmaceutical levodopa preparations.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 10/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 30/04/2025 This is a phase 2 trial Not Applicable Phase-2
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 10/07/2018 pactr update Treatment: Other Treatment: Drugs
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 30/04/2025 Logistic issues related to the site initiation visit in Ghana, by the PI (Roberto Cilia) and co-investigators (Prof Gianni Pezzoli and Prof Stanley Fahn) 04 Sep 2017 29 Jan 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 30/04/2025 Delayed completion of data collection 28 Sep 2018 23 Feb 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 02/05/2025 Updated to submit the form 23 Feb 2021 05 May 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 02/05/2025 Updated 05 May 2024 08 Feb 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 23/11/2016 The sample size for Ghana is 50 patients, 20 more patients will be recruited at the UTH in Zambia. Therefore the total sample size in Africa in 70 50 70
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 30/04/2025 The trial was supposed to take place in Ghana and Zambia. However, it could not be started in Zambia. 70 35
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 30/04/2025 The trial has been completed Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention InterventionTypeID 23/11/2016 The total number of patients had been increased to 70 (including also Zambia) to be randomized into 35 per treatment arm (experimental and control) Experimental group Experimental group
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/07/2018 pactr update Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 30/04/2025 This trial is focused on Parkinson's disease Other Nervous System Diseases, Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other disease 10/07/2018 pactr update Parkinson's Disease Parkinsons Disease
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 05/05/2025 updating Updates, updates
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 30/04/2025 The University Teaching Hospital of Lusaka could not join the trial University Teaching Hospital, Nationalist Rd, Lusaka, PO Box 5001, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/04/2025 Ethics Committee approved the trial on 24-jan-2017 FALSE, KBTH Research & Development, Guggisberg Ave, Accra, P.O. Box 77, Ghana, 02 Dec 2016, , , , TRUE, Korle Bu Teaching Hospital Scientific and Techincal Committee, Guggisberg Ave, Accra, P.O. Box 77, Ghana, 02 Dec 2016, 24 Jan 2017, +233302667759, info@kbth.gov.gh, 1882_1522_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/04/2025 Ethics Committee Approval received on 20th July 2017 FALSE, COMMITTEE ON HUMAN RESEARCH, PUBLICATIONS AND ETHICS, KATH, , Kumasi, University Post Off, Ghana, 16 Dec 2016, , , , TRUE, CHRPE, Accra Rd, Kumasi, Ghana, Kumasi, University Post Off, Ghana, 16 Dec 2016, 20 Jul 2017, +233322063248, chrpe@knust.edu.gh, 1882_1523_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/04/2025 The Universtiy Teaching Hospital of Lusaka could not join the trial and therefore the Ethics Commitee approval was not requested
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/04/2025 Ethics Committee Approval received on 31 Oct 2017 TRUE, Ghana Health Service Ethics Review Committee, P.O. Box MB 190, Accra, P.O. Box , Ghana, , 31 Oct 2017, +233302681109, ghserc@gmail.com, 1882_30597_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 30/04/2025 Moved to the National Neurological Institute Carlo Besta; Milan Roberto Cilia, via Bignami 1, Milan, 20126, Italy Roberto Cilia, via Cleoria 11, Milan, 20133, Italy
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 30/04/2025 The Teaching Hospital in Lusaka could not join the trial Masharip Atadzhanov, Nationalist Rd, Lusaka, PO Box 5001, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/04/2025 Moved to anothe Hospital (National Neurological Institute Carlo Besta) Principal Investigator, Roberto, Cilia, Dr., roberto.cilia@gmail.com, , +390257993532, via Bignami 1, Milano, 20126, Italy, Medical Doctor, Consultant Neurologist Principal Investigator, Roberto, Cilia, Dr., roberto.cilia@gmail.com, roberto.cilia@istituto-besta.it, +390223942368, Via Celoria 11, Milano, 20133, Italy, Consultant Neurologist
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/04/2025 Moved to the National Neurological Institute Carlo Besta in 2019 Public Enquiries, Roberto, Cilia, Dr., roberto.cilia@gmail.com, , +390257993532, via Bignami 1, Milano, 20126, Italy, Medical Doctor, Consultant Neurologist Public Enquiries, Roberto, Cilia, Dr., roberto.cilia@gmail.com, roberto.cilia@istituto-besta.it, +390257993532, via Bignami 1, Milano, 20126, Italy, Consultant Neurologist
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/04/2025 Moved to the National Neurological Institute Carlo Besta in 2019 Public Enquiries, Roberto, Cilia, Dr., roberto.cilia@gmail.com, roberto.cilia@istituto-besta.it, +390257993532, via Bignami 1, Milano, 20126, Italy, Consultant Neurologist Public Enquiries, Roberto, Cilia, Dr., roberto.cilia@gmail.com, roberto.cilia@istituto-besta.it, +390223952368, via Celoria 11, Milano, 20133, Italy, Consultant Neurologist
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/04/2025 Moved to the National Neurological Institute Carlo Besta in 2019 Scientific Enquiries, Roberto, Cilia, Dr., roberto.cilia@gmail.com, , +390257993532, via Bignami 1, Milano, 20126, Italy, Medical Doctor, Consultant Neurologist Scientific Enquiries, Roberto, Cilia, Dr., roberto.cilia@gmail.com, roberto.cilia@istituto-besta.it, +390223942368, via Celoria 11, Milano, 20126, Italy, Consultant Neurologist
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/05/2025 Trial registered before 2016 Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified individual participant data (IPD), including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms When will data be available (start and end dates)? Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years. With whom will data be shared? Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. For what types of analyses? Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings. How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement. Additional restrictions or requirements: • Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted. Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified individual participant data (IPD), including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/05/2025 Trial registered before 2016 Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified individual participant data (IPD), including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement. Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/05/2025 This trial was registered in 2016 Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement. Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/05/2025 Updated Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/05/2025 Updated Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement. Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymized individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will be available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/05/2025 update Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymized individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will be available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement. Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymized individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will be available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified IPD, including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 30/04/2025 The trial has been registered in 2016 Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified individual participant data (IPD), including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms When will data be available (start and end dates)? Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years. With whom will data be shared? Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. For what types of analyses? Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings. How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement. Additional restrictions or requirements: • Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/05/2025 Update Update
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/05/2025 admin update Will individual participant data (IPD) be shared? Yes, de-identified and pseudonymzed individual participant data that underlie the results reported in this article will be made available. The data supporting the findings of this study will available on request from the corresponding author. These data are not publicly available due to privacy or ethical restrictions. What data will be shared? De-identified individual participant data (IPD), including demographic, baseline, efficacy, safety, and outcome variables collected during the trial. What documents will be available? The following documents will be available: • Study protocol • Informed consent forms How can data be accessed? Researchers may submit a data access request to the corresponding author, Dr. Roberto Cilia (roberto.cilia@istituto-besta.it). Requests should include a research proposal, institutional affiliation, and a data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 30/04/2025 The trial has been registered in 2016. Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years. Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 02/05/2025 Updated Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years. Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 02/05/2025 update Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 30/04/2025 The trial has been registered in 2016 Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 05/05/2025 update update
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 05/05/2025 Admin update Data will be available starting 6 months after publication of this article and will remain accessible for a period of 3 years.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 30/04/2025 The trial has been registered in 2016. Additional restrictions or requirements: • Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted. • Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 30/04/2025 Trial registered in 2016 • Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted. - Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 02/05/2025 Key access criteria stated - Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 02/05/2025 Key access criteria stated - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings. - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 02/05/2025 This trial was registered in 2016 - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings. - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 02/05/2025 Updated - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings. - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 02/05/2025 update - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings - Access criteria will be controlled: Requesting researchers must provide ethics committee approval or a waiver if applicable. - All data will be pseudonymized, and confidentiality agreements must be signed. - No attempts to re-identify participants are permitted. - Data will be shared with qualified researchers and institutions conducting ethically approved scientific research and who provide a methodologically sound proposal. The data supporting the findings of this study will be available on request from the corresponding author. - Data will be made available for analyses that aim to replicate the study findings, validate the methodology, or address secondary research questions related to the treatment of Parkinson’s disease or therapeutic alternatives in low-resource settings.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 30/04/2025 The trial has been registered in 2016 Additional restrictions or requirements: • Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 05/05/2025 update update
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 05/05/2025 Admin update Requesting researchers must provide ethics committee approval or a waiver if applicable. • All data will be pseudonymized, and confidentiality agreements must be signed. • No attempts to re-identify participants are permitted.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 30/04/2025 The trial has been registered in 2016. https://www.who.int/tools/clinical-trials-registry-platform/network/primary-registries/pan-african-clinical-trials-registry-pactr
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 30/04/2025 Trial registered in 2016 https://www.who.int/tools/clinical-trials-registry-platform/network/primary-registries/pan-african-clinical-trials-registry-pactr
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Reporting IPD URL 05/05/2025 Updates No url
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 05/05/2025 update No url
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Reporting Study protocol document 30/04/2025 Trial registered in 2016 Study Protocol Study Protocol, Statistical Analysis Plan, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 30/04/2025 Trial registered in 2016 Study Protocol, Statistical Analysis Plan, Informed Consent Form Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 02/05/2025 Trial registered before 2016 Study Protocol Study Protocol, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 05/05/2025 update Study Protocol, Informed Consent Form Study Protocol, Statistical Analysis Plan, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 30/04/2025 The trial has been registered in 2016 Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 05/05/2025 update Study Protocol, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 05/05/2025 admin update Study Protocol, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 30/04/2025 Trial registered in 2016 No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 02/05/2025 Summary results are not available because the manuscript has been submitted. The results will be made publicly available when the manuscript will be accepted for open-access publication. Yes No
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Reporting Results Available 05/05/2025 Updates No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 05/05/2025 update No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 30/04/2025 Results are available but it is still not possible to provide them because the manuscript has been submitted and not yet accepted No No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 05/05/2025 update No No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 05/05/2025 Admin update No No
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Reporting Result Summary Pdf file1 30/04/2025 Summary results are not available because the manuscript has been submitted. 1882_24595_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 05/05/2025 update 1882_24595_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 05/05/2025 update 1882_24596_1045.pdf