Riluzole in Huntington's Disease

Huntington Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277602
• Other study ID #: RIL_DE1_201
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2006
• Last updated: February 15, 2012
• Start date: November 1999
• Est. completion date: July 2004

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• Riluzole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UHDRS-motor score, TFC