Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis (NeuroSolve)

R-Evolution Worldwide S.r.l. Impresa Sociale

Status and phase: Not yet enrolling; Phase 4

Conditions: Neurocysticercosis

Treatments: Drug: Albendazole; Drug: albendazole and praziquantel

Study type: Interventional

Funder types: Other

Identifiers

NCT06376396

101103306

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Albendazole and Praziquantel

Experimental group

Description:

This arm includes combined albendazole with praziquantel, given to approximately 150 participants. Subjects will also receive dexamethasone as an adjunct treatment. An appropriate dose will be calculated per participant's body weight and administered to each participant daily for 10 days. Participants will be monitored for 30 minutes following oral medication, and a repeat dose will be administered if a participant vomits within this observation period. Additional doses (the whole cycle) will be supplied for participants failed to clear NCC in six months.

Treatment:

Drug: albendazole and praziquantel

Albendazole

Active Comparator group

Description:

This arm includes albendazole monotherapy, given to approximately 150 participants. Subjects will also receive dexamethasone as an adjunct treatment. An appropriate dose will be calculated per participant's body weight and administered to each participant daily for 10 days. Participants will be monitored for 30 minutes following oral medication, and a repeat dose will be administered if a participant vomits within this observation period. Additional doses (the whole cycle) will be supplied for participants failed to clear NCC in six months.

Treatment:

Drug: Albendazole