Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004403
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
Sponsor:
Johns Hopkins University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-01
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:
None
Brief Summary:
OBJECTIVES I Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis
II Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain
III Determine the natural regression of cerebral T solium cysts in patients given placebo and their response to treatment at the end of the study
II Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain
III Determine the natural regression of cerebral T solium cysts in patients given placebo and their response to treatment at the end of the study
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind study Patients are randomized to receive either albendazole and dexamethasone or placebo
Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15
Patients are asked to maintain a diary Patients are followed on day 15 and 30 then every 3 months for 3 years
Completion date provided represents the completion date of the grant per OOPD records
Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15
Patients are asked to maintain a diary Patients are followed on day 15 and 30 then every 3 months for 3 years
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHUSHPH-FDR001107 | None | None | None |