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.: PACTR202003567524647 Date of Approval: 19/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
Official scientific title A randomized, double blind, parallel group clinical trial to evaluate the safety of moxidectin compared with ivermectin in individuals living in onchocerciasis endemic areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole
Brief summary describing the background and objectives of the trial The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in an onchocerciasis endemic area and in individuals living in an onchocerciasis endemic area with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Onchocerciasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2021
Actual trial start date 03/05/2021
Anticipated date of last follow up 06/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 12500
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
MDGH MOX 3002 Medicines Development for Global Health
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Moxidectin 8 mg per oral, taken once Single Dose In onchocerciasis endemic areas: Moxidectin 2 mg tablets (4x), taken orally 5000
Control Group Ivermectin Approximately 150 µg/kg per oral, taken once Single dose In onchocerciasis endemic areas: Ivermectin 3 mg tablets (approximately 150 µg/kg per oral), taken orally 1250 Active-Treatment of Control Group
Experimental Group Moxidectin with concomitant albendazole Moxidectin 8 mg per oral, taken once, with concomitant albendazole 400 mg per oral, taken once Single dose In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 2 mg tablets (4x), taken orally, with concomitant albendazole 400 mg tablet, taken orally 5000
Control Group Ivermectin with concomitant albendazole Ivermectin approximately 150 μg/kg per oral, taken once, with concommitant albendazole 400 mg per oral, taken once Single dose In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin 3 mg tablets (approximately 150 μg/kg per oral), taken orally, with concomitant albendazole 400 mg tablet, taken orally 1250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Provision of written informed consent, or assent with parental or guardian written consent. 2. Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin 3. Living in an onchocerciasis endemic area. 4. Age ≥ 4 years. 5. All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). 1. Pregnant or breast-feeding. 2. Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health. 3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline. 4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration. 5. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high LF co-endemicity requiring concomitant albendazole administration,known or suspected allergy to albendazole and its excipients 6. Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations. 7. Infection with Loa loa 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 4 Year(s) 999 Year(s) Both
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 26/08/2020 National Committee of Health Ethics
Ethics Committee Address
Street address City Postal code Country
Local 5, 1er niveau, Immeuble PNMLS C/ Kasa-Vubu Kinshasa 0000 Democratic Republic of the Congo
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 29/09/2020 World Health Organization Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
World Health Organization 20 Appia Avenue Geneva 1211 Switzerland
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 14/02/2023 National Ethics Committee for Life and Health Sciences
Ethics Committee Address
Street address City Postal code Country
Rue D19 Cocody Abidjan 0000 Cote Divoire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence and severity of treatment emergent adverse events. Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis. Pre-dose to Month 3
Secondary Outcome N/A N/A
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherche en Maladies Tropicales Hopital General de Reference de Rethy Rethy Democratic Republic of the Congo
Centre Suisse de Recherches Scientifiques en Cote Divoire 17 Rte de Dabou Abidjan Cote Divoire
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trial Partnership Anna van Saksenlaan 51 The Hague 2593 Netherlands
Medicines Development for Global Health Level 1, 18 Kavanagh Street Southbank 3006 Australia
Bill and Melinda Gates Foundation 500 5th Ave N Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medicines Development for Global Health Level 1, 18 Kavanagh Street Southbank 3006 Australia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tony Ukety tony.ukety@gmail.com +243822400101 Hopital General de Reference de Rethy
City Postal code Country Position/Affiliation
Rethy Democratic Republic of the Congo Centre de Recherche en Maladies Tropicales
Role Name Email Phone Street address
Public Enquiries Sally Kinrade sally.kinrade@medicinesdevelopment.com +61399122400 Level 1, 18 Kavanagh Street
City Postal code Country Position/Affiliation
Southbank 3006 Australia Moxidectin for Onchocerciasis Project Leader
Role Name Email Phone Street address
Scientific Enquiries Sally Kinrade sally.kinrade@medicinesdevelopment.com +61399122400 Level 1, 18 Kavanagh Street
City Postal code Country Position/Affiliation
Southbank 3006 Australia Moxidectin for Onchocerciasis Project Leader
Role Name Email Phone Street address
Principal Investigator Benjamin Koudou guibehi.koudou@csrs.ci +225777205263 17 Rte de Dabou
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Centre Suisse de Recherches Scientifiques en Cote Divoire
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data to be shared: anonymised demographic, baseline data and primary outcome Clinical Study Report Following finalisation of the Clinical Study Report and initial publications, anticipated Q1, 2025 Controlled access. Requests anticipated from researchers. Decision made by Sponsor in consultation with site, on the following criteria: quality/purpose of request, and mutual agreement regarding publication planning and confidentiality provisions.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information