Riluzole in Huntington's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00277602
First received: January 13, 2006
Last updated: February 15, 2012
Last verified: February 2012

January 13, 2006
February 15, 2012
November 1999
July 2004   (final data collection date for primary outcome measure)
UHDRS-motor score, TFC
Not Provided
Complete list of historical versions of study NCT00277602 on ClinicalTrials.gov Archive Site
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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

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Huntington Disease
Drug: Riluzole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
537
July 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Huntington's disease and CAG repeat length of 36 or more
  • UHDRS Motor score of at least 5 points
  • UHDRS TFC score of at least 8 points, i.e. patients must be independently ambulatory and must not require nursing care
  • Females require a negative blood pregnancy test at inclusion

Exclusion Criteria:

  • Any forms of chorea other than Huntington's disease
  • Patients on antichoreic treatment within one month prior to entry or foreseen to require such treatment within the first 3 months after randomization (antichoreic medication is prohibited during entire study)
  • Other unacceptable prior/concomitant medications
  • Uncontrolled major psychiatric disorders, in particular uncontrolled major depression (DSM IV definition)
  • Drug or alcohol dependence and/or abuse (DSM IV definition) within the past 6 months
  • Any other concomitant disease with a reasonable possibility to interfere with the study
  • Females who are breast-feeding, not sterilized, at least one year postmenopausal or don't use an adequate contraceptive method for at least one month prior to and during study participation
  • Participation in another clinical study with any investigational drug within 30 days prior to study screening
  • Prior exposure to riluzole
  • ALT and/or AST and/or Total Bilirubin levels greater than 1.5 times the upper limits of normal range, or hepatic disease other than Gilbert's disease
  • Creatinine serum concentrations above 200 µmol/l (resp. 2,3 mg/dl) or hematology parameters as follows: Hemoglobin smaller 11 g/dl for males resp. smaller 10 g/dl for females, or White Blood Cell smaller 3,5 x 10000000000/l
Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00277602
RIL_DE1_201
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP