Back to resultsCARE Canadian ALS Riluzole Evaluation
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Riluzole
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ALS confirmed by the following definition:
(a)"Probable" or "Definite" Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria(b)"Peripheral" onset form (limb involvement) or a "Bulbar" form of ALS with a duration of five years, based on inquiry for the earliest symptoms of the disease
- A subject who simultaneously presents with bulbar and peripheral signs at onset of ALS disease should be stratified to the bulbar onset group. The neurologic progression of such subjects matches that of the bulbar onset ALS subjects.
- Pulmonary Function: forced vital capacity (FVC) must be 3 60% at study entry.
- Females of childbearing potential must be documented to be using acceptable birth control methods such as an IUD or oral contraceptives.
Exclusion Criteria:
- Previous treatment with riluzole
- Tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion
- Signs of clinical dementia and/or major psychiatric disorders
- Serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival
- A multiple conduction block has been shown on nerve conduction studies by electromyogram
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542412
Brief Title
CARE Canadian ALS Riluzole Evaluation
Official Title
Care (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical Controls
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (ALS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
414 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Riluzole
Primary Outcome Measure Information:
Title
The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ALS confirmed by the following definition:
(a)"Probable" or "Definite" Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria(b)"Peripheral" onset form (limb involvement) or a "Bulbar" form of ALS with a duration of five years, based on inquiry for the earliest symptoms of the disease
A subject who simultaneously presents with bulbar and peripheral signs at onset of ALS disease should be stratified to the bulbar onset group. The neurologic progression of such subjects matches that of the bulbar onset ALS subjects.
Pulmonary Function: forced vital capacity (FVC) must be 3 60% at study entry.
Females of childbearing potential must be documented to be using acceptable birth control methods such as an IUD or oral contraceptives.
Exclusion Criteria:
Previous treatment with riluzole
Tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion
Signs of clinical dementia and/or major psychiatric disorders
Serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival
A multiple conduction block has been shown on nerve conduction studies by electromyogram
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent-Didier Jacobs
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Laval
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
CARE Canadian ALS Riluzole Evaluation
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