Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00277602
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2006-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Riluzole in Huntington's Disease
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase III Multicenter, Double-Blind, Parallel-Group, Placebo Controlled Study to Measure the Effect of Riluzole 50 mg b.i.d. Over a Period of Three Years on the Progression of Huntington's Disease
Status:
COMPLETED
Status Verified Date:
2012-02
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:
Primary objective:
* The primary objective of the study is to establish that riluzole slows down (1) the decrease in total functional capacity (TFC), (2) the increase of the motor score of the Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a combined score of these.
Secondary objectives:
Secondary objectives are to assess
* changes in the other UHDRS subscales
* the number of patients who need antichoreic treatment and the time until this treatment has to be initiated
* the safety/tolerability of riluzole in Huntington patients
* The primary objective of the study is to establish that riluzole slows down (1) the decrease in total functional capacity (TFC), (2) the increase of the motor score of the Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a combined score of these.
Secondary objectives:
Secondary objectives are to assess
* changes in the other UHDRS subscales
* the number of patients who need antichoreic treatment and the time until this treatment has to be initiated
* the safety/tolerability of riluzole in Huntington patients
Detailed Description:
None
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?: