drugset / Trial / NCT00277602

Riluzole in Huntington's Disease

NCT00277602

Phase 3 Completed 537 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
1999-11
Primary completion
2004-07
Completion
2004-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Riluzole Small molecule 50 mg

Indications