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.: PACTR202402822223203 Date of Approval: 15/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of combined antiparasitic drugs praziquantel and albendazole versus albendazole alone in the treatment of active parenchymal neurocysticercosis in Tanzania and Zambia.
Official scientific title Assessment of combined antiparasitic drugs praziquantel and albendazole versus albendazole alone in the treatment of active parenchymal neurocysticercosis in Tanzania and Zambia.
Brief summary describing the background and objectives of the trial Among the Taenia solium-caused forms of human cysticercosis, neurocysticercosis is a major contributor to the global burden of seizure disorders and epilepsy, despite having relatively poor clinical evidence on treatment, necessitating additional data, primarily from additional randomized controlled trials. The two parasiticides indicated for use in treating active neurocysticercosis (NCC) are albendazole and praziquantel. Albendazole is specifically suggested for patient with a single cyst, while a combination therapy of albendazole and praziquantel is recommended for those with multiple cysts. Albendazole monotherapy, however, does not work for all patients with single cysts. Combination therapy may be effective in patients with single cysts, as it has been demonstrated to be effective in those with multiple cysts. However, it is unknown whether combination therapy has varying efficacy in curing neurological symptoms/signs, or whether demographic characteristics such as age or sex has influence. The majority of NCC treatment success studies have been undertaken in Latin America or India, while investigations in India focused mostly on single cystic lesion. Despite the fact that the parasite is known to be endemic in Sub Saharan Africa (SSA), no research on the effectiveness of the recommended treatment has been undertaken in this region. Furthermore, due to probable variances in genetic, clinical, and environmental factors, extrapolating findings from other locations to SSA may not be realistic. Overall Design Disclosure statement: This is a randomized, open-label clinical trial to assess if the combination of antiparasitic praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal neurocysticercosis in Tanzania and Zambia. Individuals diagnosed to have neurocysticercosis were recently managed according to experts’ opinion although the WHO guideline for the management of NCC has been released.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NeuroSolve
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Neurocysticercosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/05/2024
Actual trial start date
Anticipated date of last follow up 30/11/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Albendazole alone 15mg/kg/day (maximum 1200mg/day) 10 days Control intervention 150 Active-Treatment of Control Group
Experimental Group Albendazole plus Praziquantel Tabs Albendazole at a dose of 15mg/kg/d (maximum 1200mg/day) divided into two doses together with tabs of Praziquantel at a dose of 50mg/kg/d in two divided doses, 10 days Interventional arm 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion for screening: • Living in the study area for a continuous period of 3 years • Late onset/acquired epilepsy • Adult aged 18 years and above • Are willing and able to consent to this study • Are willing to undergo diagnostic procedures Inclusion criteria for the treatment study: • Adult aged 18 years and above • Are willing and able to consent to this study • Meet the definitions of active symptomatic NCC • Have late onset of epilepsy or history of seizures, epileptic seizures • Are willing to undergo diagnostic procedures • Are medically stable enough for trial medication to be initiated • Are willing to be hospitalized for 11-20 days to receive treatment for NCC • Are willing to be followed up for one year following receipt of study medication The participants will be excluded if; • Are pregnant or breastfeeding • Symptomatic NCC with cysts in extra-parenchymal location (sub-arachnoid and/or ventricles) • Have uncontrolled hypertension and/or diabetes • Have chronic consuming illness such as cancer or mental handicap to not allow them to follow the study instructions • Have severe immunodeficiency eg. HIV/AIDS or Autoimmune diseases • Already known allergies to albendazole • Subject taking part in another clinical/pharmacological study in the 30 days preceding enrollment 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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
No 29/02/2024 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cysts resolution or reduction in both study arms. At 6 months and 1 year after the treatment
Secondary Outcome 1. Seizure frequency 2. Quality of life 3. Headache severity and frequency 4. Immunological test results At 6 months and 1 year after the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Dar es Salaam Mbeya College of Health and Allied Science UDSM MCHAS Hospital Hill Road Mbeya United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health European and Developing Countries Clinical Trials Partnership 3 Joint Undertaking GH EDCTP3 JU Avenue de la Toison d Or Gulden Vlieslaan 56-60 Brussels 1060 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor REvolution Worldwide S.r.l. Impresa Sociale via Angelo Selleri 35 Maglie 73024 Italy Scientific NGO
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernard Ngowi b_ngowi@yahoo.co.uk +255763918181 Hospital Hill Road
City Postal code Country Position/Affiliation
Mbeya United Republic of Tanzania Lecturer
Role Name Email Phone Street address
Public Enquiries Kabemba Evans Mwape evans.mwape@unza.zm +260211293727 164 Great East Road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Helena Ngowi helenangowi@gmail.com +255754374839 Chuo Kikuu
City Postal code Country Position/Affiliation
Morogoro 67125 United Republic of Tanzania Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share the de-identified data on efficacy and safety during publication of the study results. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months after study completion Open access
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