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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00542412 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study ID Numbers: | RIL_CA1_401 |
Study First Received: | October 10, 2007 |
Last Updated: | October 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00542412 |
Health Authority: | Canada: Ethics Review Committee |
Riluzole Excitatory Amino Acids Spinal Cord Diseases Central Nervous System Diseases Sclerosis Degenerative motor system disease Neurodegenerative Diseases |
Motor neuron disease Amyotrophic lateral sclerosis Neuromuscular Diseases Amyotrophic Lateral Sclerosis Lou Gehrig's disease Motor Neuron Disease |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Excitatory Amino Acid Agents Neuroprotective Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |