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Riluzole in Huntington's Disease

Primary Purpose

Huntington Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Riluzole
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    UHDRS-motor score, TFC

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2006
    Last Updated
    February 15, 2012
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00277602
    Brief Title
    Riluzole in Huntington's Disease
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1999 (undefined)
    Primary Completion Date
    July 2004 (Actual)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Huntington Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    537 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Riluzole
    Primary Outcome Measure Information:
    Title
    UHDRS-motor score, TFC

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Sciences & Operations
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26714284
    Citation
    Schramm C, Katsahian S, Youssov K, Demonet JF, Krystkowiak P, Supiot F, Verny C, Cleret de Langavant L, Bachoud-Levi AC; European Huntington's Disease Initiative Study Group and the Multicentre Intracerebral Grafting in Huntington's Disease Group. How to Capitalize on the Retest Effect in Future Trials on Huntington's Disease. PLoS One. 2015 Dec 29;10(12):e0145842. doi: 10.1371/journal.pone.0145842. eCollection 2015.
    Results Reference
    derived

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    Riluzole in Huntington's Disease

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