A study of riluzole in the treatment of advanced stage or elderly patients with amyotrophic lateral sclerosis

• Published in: Journal of neurology Vol. 249; no. 5; pp. 609 - 615
• Main Authors: BENSIMON, G, LACOMBLEZ, L, DELUMEAU, J. C, BEJUIT, R, TRUFFINET, P, MEININGER, V
• Format: Journal Article
• Language: English
• Published: Berlin Springer 01.05.2002; Springer Nature B.V
• Subjects: Age Factors; Aged; Amyotrophic Lateral Sclerosis - drug therapy; Amyotrophic Lateral Sclerosis - physiopathology; Biological and medical sciences; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases; Disease Progression; Double-Blind Method; Drug Tolerance - physiology; Female; Humans; Male; Medical sciences; Middle Aged; Multicenter Studies as Topic; Neurology; Neuropharmacology; Neuroprotective agent; Neuroprotective Agents - administration & dosage; Neuroprotective Agents - adverse effects; Patient Selection; Pharmacology. Drug treatments; Riluzole - administration & dosage; Riluzole - adverse effects; Survival Rate; Treatment Outcome; Human; Nervous system diseases; Psychotropic; Benzothiazole; Treatment efficiency; Tolerance; Amyotrophic lateral sclerosis; Neuroprotective agent; Riluzole; Chemotherapy; Central nervous system disease; Degenerative disease; Spinal cord disease; Elderly
• ISSN: 0340-5354; 1432-1459
• DOI: 10.1007/s004150200071

Treatment with the neuroprotective drug riluzole has previously been shown to increase the probability of survival in patients with amyotrophic lateral sclerosis. This report describes a placebo-controlled, double-blind randomised clinical trial of riluzole carried out in ALS patients with advanced stage disease or aged over 75 years. The primary objective was to enable access to treatment to patients excluded from the pivotal trial which was run in parallel. Another goal was to assess the safety of riluzole in patients with advanced-stage disease. One hundred and sixty-eight patients were included, randomised to either riluzole 50 mg b. i. d. or to placebo, and treated for eighteen months. Riluzole was well-tolerated in this patient population, and the adverse events observed were similar in nature and frequency to those observed in previously published clinical trials in patients included in pivotal trials. The study could not include enough patients to reach adequate power to detect differences in survival between the two treatment groups, and no such difference was in fact observed. In conclusion, riluzole is well-tolerated in ALS patients with advanced stage disease.