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Journal of Neurology

, Volume 249, Issue 5, pp 609–615 | Cite as

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

  • G. Bensimon
  • L. Lacomblez
  • J. C. Delumeau
  • R. Bejuit
  • P. Truffinet
  • V. Meininger
  • for the Riluzole/ALS Study Group III
ORIGINAL COMMUNICATION

Abstract

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.

Key words amyotrophic lateral sclerosis riluzole clinical trial patients 

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Copyright information

© Steinkopff Verlag 2002

Authors and Affiliations

  • G. Bensimon
    • 1
  • L. Lacomblez
    • 1
  • J. C. Delumeau
    • 2
  • R. Bejuit
    • 2
  • P. Truffinet
    • 2
  • V. Meininger
    • 3
  • for the Riluzole/ALS Study Group III
  1. 1.Dept. Pharmacologie Clinique, Centre Hospitalier Universitaire Pitié-Salpêtrière, Assistance Publique Hôpitaux de Paris & Université Pierre & Marie Curie, 75013 Paris, FranceFrance
  2. 2.Aventis Pharma, 20, avenue Raymond Aron, 92165 Antony, FranceFrance
  3. 3.Fédération de Neurologie Mazarin, Centre Hospitalier Universitaire Pitié-Salpêtrière, Assistance Publique Hôpitaux de Paris et Université Pierre & Marie Curie, 75013 Paris, France, Tel.: +33-1/42 16 04 26France

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