Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565507
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Oxfendazole in Mild Parenchymal Brain Cysticercosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Multicenter Randomized Controlled Trial of Single and Multiple Dose Regimens of Oxfendazole for Mild One or Two Lesions Parenchymal Brain Cysticercosis With an Open Comparison Group
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild one or two lesions parenchymal brain cisticercosis The main question it aims to answer is if OXF will enhance clearance of brain parasites and therefore provide greater cysticidal efficacy with the potential to provide a single-dose therapy for this type of NCC
The study cohort will also allow us to identify early imaging markers that predict lesion resolution as well as factors associated with residual calcification or focal gliosis after lesion resolution This study will also provide additional information on the safety of the study interventions
The study cohort will also allow us to identify early imaging markers that predict lesion resolution as well as factors associated with residual calcification or focal gliosis after lesion resolution This study will also provide additional information on the safety of the study interventions
Detailed Description:
This three-arm randomized controlled phase IIIII clinical trial will compare the efficacy and safety of a single-dose regimen with 20 mgkg oxfendazole and a regimen with three similar doses spread over seven days day 1 day 4 and day 7 with the most effective antiparasitic regimen available combined albendazole plus praziquantel for ten days in individuals with mild NCC with one to two lesions
Participants will receive treatment with oxfendazole one or three dose regimens or the standard treatment albendazole praziquantel At day 15 after treatment onset an MRI will be perfomed to evaluate early predictors of lesion resolution MRI at day 90 will serve to evaluate efficacy lesion resolution and a day 180 MRI will evaluate sequelar lesions CT will be perfomed at the en of the study to confirm persistence of calcified sequelar lesion
The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions all in a single brain area Lesions can be one or two adjacent viable or degenerating NCC lesions Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement
Participants will receive treatment with oxfendazole one or three dose regimens or the standard treatment albendazole praziquantel At day 15 after treatment onset an MRI will be perfomed to evaluate early predictors of lesion resolution MRI at day 90 will serve to evaluate efficacy lesion resolution and a day 180 MRI will evaluate sequelar lesions CT will be perfomed at the en of the study to confirm persistence of calcified sequelar lesion
The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions all in a single brain area Lesions can be one or two adjacent viable or degenerating NCC lesions Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None