Clinical trial NCT06376396: Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
Official title: Assessment of Combined Antiparasitic Drugs Praziquantel and Albendazole Versus Albendazole Alone in the Treatment of Active Parenchymal Neurocysticercosis in Tanzania and Zambia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Neurocysticercosis
Keywords: Neglected Tropical Disease
Epilepsy
Lead sponsor: R-Evolution Worldwide S.r.l. Impresa Sociale
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
name: National Institute for Medical Research, Tanzania
name: Sokoine University of Agriculture
name: University of Zambia
name: University Ghent
First posted: 2024-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis.

Detailed description: This is a randomized, two arms, parallel-groups, 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.

Background and Study Rationale: between the forms of human cysticercosis caused by Taenia solium, neurocysticercosis is a major contributor to the burden of seizure disorders and epilepsy in most of the world, while it has relatively poor clinical evidence on treatment options, requiring further data, mainly from additional randomized controlled trials. In particular albendazole and praziquantel are the two parasiticides recommended for use in treating active neurocysticercosis (NCC). Specifically, albendazole is recommended for use in patients with a single cyst while both albendazole and praziquantel (combination therapy) are recommended for patients with multiple cysts. However, not all patients with single cysts respond to albendazole monotherapy. Combination therapy may be effective in patients with single cysts as it has already been shown effective for multiple cysts.

Most studies of treatment success for NCC have been conducted in Latin America and India. In India, the studies were performed primarily on singular cystic lesions. Despite Sub-Saharan Africa (SSA) being recognized as endemic for this parasite, no study evaluating the success of standard treatment in humans has been conducted in this region. Additionally, it is difficult to extrapolate information from other regions other than SSA due to possible differences in genetic, clinical, and environmental factors.

Primary Objective:

The primary objective of this study is to determine if the anthelmintics combination of praziquantel and albendazole is better than albendazole alone in the treatment of the active parenchymal neurocysticercosis based on cyst resolution.

Secondary Objectives:

1. To determine if the combination of antiparasitic praziquantel and albendazole is better than albendazole alone in the treatment of active parenchymal neurocysticercosis based on seizures reduction
2. To estimate the change in quality of life of patients with active symptomatic NCC before and after treatment with combined antiparasitic treatment and mono...
3. To assess the role of serology in diagnosis, management and follow up of participants treated for neurocysticercosis.

Eligibility criteria: Inclusion Criteria:

* 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
* Have late onset of epilepsy or history of seizures, epileptic seizures
* Subjects willing to undergo diagnostic procedures
* Subjects medically stable enough for trial medication to be initiated
* Subjects willing to be hospitalized for 11-20 days to receive treatment for NCC
* Subjects willing to be followed up for one year following receipt of study medication

Exclusion Criteria:

* 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
* Have severe immunodeficiency eg. HIV/AIDS or Autoimmune diseases
* Already known allergies to albendazole or praziquantel
* Subject taking part in another clinical/pharmacological study in the 30 days preceding enrollment

Primary outcomes:
measure: Cyst resolution or reduction in both study arms
timeFrame: 6 weeks and 6 months
Secondary outcomes:
measure: Seizures frequency
timeFrame: 6 weeks and 6 months
measure: Quality of Life questionnaire
timeFrame: 6 weeks, 6 months and 1 year
measure: Headache
timeFrame: 6 weeks, 6 months and 1 year
measure: Serological test results correlation with neuroimaging results
timeFrame: Baseline, 6 weeks, 6 months and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Zambia
name: Kabemba E. Mwape, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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