CARE Canadian ALS Riluzole Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Riluzole

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Laurent-Didier Jacobs

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Laval, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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RIL_CA1_401

Identifier Type: -

Identifier Source: org_study_id