Status:
COMPLETED
Riluzole in Huntington's Disease
Lead Sponsor:
Sanofi
Conditions:
Huntington Disease
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
Brief 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 Unifie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
537 Patients enrolled
Trial Details
Trial ID
NCT00277602
Start Date
November 1 1999
End Date
July 1 2004
Last Update
February 17 2012
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