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
  Purpose

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

Condition Intervention Phase
Huntington Disease
Drug: Riluzole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • UHDRS-motor score, TFC

Enrollment: 537
Study Start Date: November 1999
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277602

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00277602     History of Changes
Other Study ID Numbers: RIL_DE1_201
Study First Received: January 13, 2006
Last Updated: February 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Chorea
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Riluzole
Anticonvulsants
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014