CARE Canadian ALS Riluzole Evaluation

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542412
• Other study ID #: RIL_CA1_401
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2007
• Last updated: October 10, 2007
• Start date: January 2001
• Est. completion date: December 2004

Study information

• Verified date: October 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Intervention

Drug:
• Riluzole

Locations

Country	Name	City	State
Canada	Sanofi-Aventis	Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)