- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00277602
Riluzole in Huntington's Disease
February 15, 2012 updated by: Sanofi
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
537
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
UHDRS-motor score, TFC
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1999
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
January 13, 2006
First Submitted That Met QC Criteria
January 13, 2006
First Posted (Estimate)
January 16, 2006
Study Record Updates
Last Update Posted (Estimate)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 15, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Neuroprotective Agents
- Protective Agents
- Anticonvulsants
- Riluzole
Other Study ID Numbers
- RIL_DE1_201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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