CARE Canadian ALS Riluzole Evaluation
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis
Intervention: Riluzole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Laurent-Didier Jacobs, Study Director, Affiliation: Sanofi-Aventis
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).
Clinical Details
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 design: Treatment, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Laval, Quebec, Canada
Additional Information
Starting date: January 2001
Ending date: December 2004
Last updated: October 10, 2007
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