Riluzole in 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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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riluzole

Drug

Primary outcomes

UHDRS-motor score, TFC

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start: 1999
Primary completion: 2004
Study completion: 2004
First posted: Jan 16, 2006
Registry last updated: Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed