Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01585207
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2012-04-24
Brief Title:
Proof-of-Concept Safety Study of CPP-109 Vigabatrin for Treatment Refractory Tourettes Disorder
Sponsor:
Barbara J Coffey
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Open Label Safety and Tolerability Trial of CPP-109 Vigabatrin in Adults With Treatment Refractory Tourettes Disorder
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The purpose of this study is to determine if vigabatrin an unusual anti-seizure medication will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted into adulthood and have not responded to usual treatment
Detailed Description:
The aims of this study are to 1 explore proof of concept that CPP-109 will reduce tics and 2 to obtain systematic data regarding dosing safety and tolerability of CPP-109 in adults with treatment refractory TD We will obtain preliminary data on estimate of effect size for tics using Cohens d calculating the difference between the two means baseline and endpoint scores on the YGTSS divided by the standard deviation of the difference
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11-01864 | None | None | None |