Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376396
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-02-25
Brief Title:
Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
Sponsor:
R-Evolution Worldwide Srl Impresa Sociale
Organization:
R-Evolution Worldwide Srl Impresa Sociale
Study Overview
Official Title:
Assessment of Combined Antiparasitic Drugs Praziquantel and Albendazole Versus Albendazole Alone in the Treatment of Active Parenchymal Neurocysticercosis in Tanzania and Zambia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeuroSolve
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None