Riluzole in Huntington's Disease | NCT00277602

Studies
Riluzole in Huntington's Disease

NCT00277602

Sponsor

Sanofi

Status

Completed

Last Update Posted

Feb 17, 2012Estimated

Enrollment

537Actual

Phase

Phase 3

Conditions

Huntington Disease

Interventions

Riluzole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1999

Primary Completion Date

Jul 2004Actual

Completion Date

Jul 2004Actual

First Submitted Date

Jan 13, 2006

First Submission Date that Met QC Criteria

Jan 13, 2006

First Posted Date

Jan 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2012

Last Update Posted Date

Feb 17, 2012Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

537Actual

Name	Type	Description	Arm Group Labels	Other Names
Riluzole	Drug

Measure	Description	Time Frame
UHDRS-motor score, TFC

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26714284	Derived	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.

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D052160	Benzothiazoles