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Huntington DiseasePhase 3NCT00277602

Riluzole in Huntington's Disease

A Phase 3 study testing Riluzole in people with Huntington Disease, run by Sanofi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Huntington Disease
What is being tested?
Riluzole
How many people
537 participants
Where
No sites listed yet
Study dates
Nov 1999to Jul 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

About this study

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

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
Being tested
Riluzole
Medical subject headings
Huntington Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RiluzoleDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UHDRS-motor score, TFC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2006 (estimated)
  2. Study startNov 1999
  3. Primary completionJul 2004
  4. Study completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277602
Sponsor's protocol ID
RIL_DE1_201
Status last verified
Feb 2012
First submitted
13 Jan 2006
Last updated
17 Feb 2012
Results posted
No

Publications

  • 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.

    PubMed 26714284

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Riluzole in people with Huntington Disease, run by Sanofi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UHDRS-motor score, TFC. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00277602, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.

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