CARE Canadian ALS Riluzole Evaluation

NCT00542412 | Completed Phase 4

• 1 other identifier: RIL_CA1_401
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)

Interventions

Riluzole DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous treatment with riluzole
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Laval, Quebec, Canada

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Laurent-Didier Jacobs

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: January 1, 2001
• Study Completion: December 1, 2004
• Last Updated: October 11, 2007

Record last verified: 2007-10

Locations

CA (1)