The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.
Living in the study area for a continuous period of 3 years
Adult aged 18 years and above
Are willing and able to consent to this study
Meet the definitions of active symptomatic NCC
Women 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
Parallel
albendazole and praziquantel
DrugCombination of albendazole plus praziquantel
Albendazole
DrugAlbendazole alone
Cyst resolution or reduction in both study arms
The primary objective of this study is to determine if the anthelmintic combination of praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal cysticercosis, based on cyst resolution. The cysts resolution is defined by at least 70% resolution at brain imaging (CT scan / MRI) between the baseline imagines and those at 6-week to 6-month following treatment.
Seizures frequency
Reduction of seizures frequency at 6-weeks to 6-months following treatment
Quality of Life questionnaire
The improvement in Quality of life (QoL) at 6-weeks, 6-months and 12-months following treatment.
Headache
The headache severity and frequency will be assessed by in-depth neurological examination, including patient-reported outcome measures (e.g. VAS - Visual Analog Scale), at the following defined time point: baseline, 6 weeks, 6 months and 1 year
Serological test results correlation with neuroimaging results
To assess the role of serology in diagnosis, management and follow up of participants treated for neurocysticercosis, antigen and antibody detecting tests results will be done and the results will be compared with neuroimaging (CT/MRI), at baseline, 6-week, 6-month and 1 year following treatment.
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R-Evolution Worldwide S.r.l. Impresa Sociale
Lead sponsor
Muhimbili University of Health and Allied Sciences
Collaborator
National Institute for Medical Research, Tanzania
Collaborator
Sokoine University of Agriculture
Collaborator
University of Zambia
Collaborator
University Ghent
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
