Riluzole in Huntington's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277602
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

January 13, 2006
January 16, 2006
February 17, 2012
November 1999
July 2004   (Final data collection date for primary outcome measure)
UHDRS-motor score, TFC
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Complete list of historical versions of study NCT00277602 on 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
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Huntington Disease
Drug: Riluzole
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Schramm C, Katsahian S, Youssov K, Démonet JF, Krystkowiak P, Supiot F, Verny C, Cleret de Langavant L, Bachoud-Lévi AC; European Huntington's Disease Initiative Study Group and the Multicentre Intracerebral Grafting in Huntington's Disease Group. How to Capitalize on the Retest Effect in Future Trials on Huntington's Disease. PLoS One. 2015 Dec 29;10(12):e0145842. doi: 10.1371/journal.pone.0145842. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Clinical Sciences & Operations Sanofi
February 2012

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