Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00730522
Status:
TERMINATED
Last Update Posted:
2020-12-09
First Post:
2008-08-05
Brief Title:
Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
Sponsor:
Catalyst Pharmaceuticals Inc
Organization:
Catalyst Pharmaceuticals Inc
Study Overview
Official Title:
Vigabatrin for Treatment of Methamphetamine Dependence A Phase II Study
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
To conserve remaining capital Sponsor decided to terminate the study early
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the studys Treatment Phase Weeks 11 and 12
Detailed Description:
This is a Phase II randomized double-blind placebo-controlled intent-to-treat 2-arm parallel design multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction The study will involve approximately 180 subjects 90group who meet DSM IV criteria for methamphetamine dependence Subjects will be evaluated for their compliance with protocol inclusionexclusion criteria during ScreeningBaseline Phase lasting up to 4 weeks
At the conclusion of the ScreeningBaseline Phase subjects meeting all inclusionexclusion criteria will be randomized to one of two treatment groups vigabatrin or placebo Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period Subjects will be scheduled for clinic visits 3 times per week for efficacy andor safety assessments during the ScreeningBaseline Phase and the 12 week Treatment Phase Subjects will return for follow up visits at Weeks 13 16 20 and 24
At the conclusion of the ScreeningBaseline Phase subjects meeting all inclusionexclusion criteria will be randomized to one of two treatment groups vigabatrin or placebo Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period Subjects will be scheduled for clinic visits 3 times per week for efficacy andor safety assessments during the ScreeningBaseline Phase and the 12 week Treatment Phase Subjects will return for follow up visits at Weeks 13 16 20 and 24
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