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 COLLEGEVILLE, Pa., March 1 /PRNewswire/ -- Results of a study published in this week's New England Journal of Medicine show that riluzole, an antiglutamate drug, is potentially active in Amyotrophic Lateral Sclerosis (ALS), a disease of the motor neurons -- the nerves that control muscle movement. The double-blind, placebo-controlled trial, which was conducted at sites throughout France and in Belgium, was the first to test the safety and efficacy of riluzole in ALS patients.
 According to the study investigators and officials at Rhone-Poulenc Rorer (NYSE: RPR), the sponsor of the trial, further clinical trials are necessary to confirm these results and to determine the appropriate dose before riluzole can be considered as a potential treatment for ALS.
 In a paper titled, "A Controlled Trial of Riluzole in Amyotrophic Lateral Sclerosis," the authors state that riluzole significantly increased survival and decreased the muscle deterioration rate, as compared with placebo.
 The effect on survival was observed to be most significant in ALS patients with bulbar onset, which is known to have a more rapid disease progression than in patients with limb onset. Study participants included 32 bulbar onset and 123 limb onset patients.
 The authors stated that "The favorable effect of riluzole on survival seems to depend on the site of onset of disease." A large and significant effect was observed in patients with ALS of bulbar onset. In the limb onset patient group, a trend toward a positive effect was detected. The reason for the differences in bulbar onset patients is not known.
 Riluzole also slowed the deterioration of muscle function, which suggests that the drug may interfere with the disease process.
 The study examined the principal efficacy endpoints of survival and changes in functional status. Secondary assessments were muscle testing scores, measures of respiratory function, patient's subjective evaluations of symptoms, global clinical impressions, as well as the ability of patients to tolerate the treatment. The trial was conducted according to Good Clinical Practice guidelines.
 Patients were given either 100 mg of riluzole as 50 mg tablets or placebo taken twice daily for a period of one year. There were 77 patients who received riluzole (62 limb onset and 15 bulbar onset) and 78 who received placebo (61 limb onset and 17 bulbar onset).
 The most frequent adverse drug reactions included worsening of asthenia (weakness), worsening of spasticity, and aminotransferase increases (alanine aminotransferase, ALT or aspartate aminotransferase, AST). Treatment was discontinued in 44 patients during the study (riluzole = 27, placebo = 17).
 ALS is a progressive and fatal neurodegenerative disorder that usually starts in middle age. Survival ranges from a few months to decades (median survival time is 37 to 49 months). Currently, there is no treatment shown to influence survival. The origin of the disease is unknown. ALS is known internationally by several different names, including Lou Gehrig's disease (U.S.), Maladie de Charcot (France) and Motor Neurone Disease (UK).
 To answer questions about ALS and its potential treatments, people are encouraged to call either The Amyotrophic Lateral Sclerosis Association at 1-800-782-4747 or The Muscular Dystrophy Association at 1-800-572-1717 in North America and the International Alliance of MND/ALS Associations at 44-0-604-250505 in Europe.
 Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health.
 /NOTE TO EDITORS: RPR is conducting a second trial, which is necessary to validate the safety and efficacy observed in the first trial and to determine the optimal dose for riluzole. This trial is scheduled for completion in April, 1995. We are planning to conduct an interim analysis of the clinical data in the fall of 1994. All available resources will be used to file for marketing authorization as soon as possible after efficacy is confirmed./
 -0- 3/1/94
 /CONTACT: Bob Pearson of Rhone-Poulenc Rorer, 215-454-3872, or Nigel Waskett, M.D., 011-33-1-40-91-4343, for Rhone-Poulenc Rorer/

CO: Rhone-Poulenc Rorer ST: Pennsylvania IN: MTC SU:

JM -- PH034 -- 6408 03/01/94 17:48 EST
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Publication:PR Newswire
Date:Mar 1, 1994

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