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CARE Canadian ALS Riluzole Evaluation

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00542412
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Riluzole
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Enrollment: 414
Study Start Date: January 2001
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542412

Locations
Canada, Quebec
Sanofi-Aventis
Laval, Quebec, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Laurent-Didier Jacobs Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00542412     History of Changes
Other Study ID Numbers: RIL_CA1_401
Study First Received: October 10, 2007
Last Updated: October 10, 2007
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Motor Neuron Disease
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Riluzole
Anticonvulsants
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014