Trials / Completed
CompletedNCT00277602
Riluzole in Huntington's Disease
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 537 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Riluzole |
Timeline
- Start date
- 1999-11-01
- Primary completion
- 2004-07-01
- Completion
- 2004-07-01
- First posted
- 2006-01-16
- Last updated
- 2012-02-17
Source: ClinicalTrials.gov record NCT00277602. Inclusion in this directory is not an endorsement.