CARE Canadian ALS Riluzole Evaluation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00542412
• Date of registration: 10/10/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: CARE Canadian ALS Riluzole Evaluation
• Scientific 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
• Date of first enrolment: January 2001
• Target sample size: 414
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00542412
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Laurent-Didier Jacobs
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Riluzole

Primary Outcome(s)

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

Secondary ID(s)

RIL_CA1_401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors