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Richard A. Rudick, MD; Diane Breton, RN, MS; Ronald L. Krall, MD

Arch Neurol. 1987;44(10):1033-1036.

Abstract
• Thirty-two patients with spasticity due to multiple sclerosis were entered into a randomized, double-blinded, placebo-controlled crossover trial of the -aminobutyric acid agonist, progabide. Each patient was treated with a maximum of 45 mg/kg of progabide during each of two four-week treatment periods, separated by a two-week washout. Twentyfive participants completed the study; seven failed to complete the study due to adverse events. Progabide was associated with lessened spasticity. There was no loss of motor power associated with progabide. The physician, patients, and study nurse coordinator all declared preferences for progabide for treatment of spasticity. Ten participants (40%) chose to remain on progabide in an open, long-term follow-up protocol. Seven serious adverse events occurred. One consisted of fever and weakness without infection; the other six consisted of elevated aspartate aminotransferase and alanine aminotransferase levels, four of which were asymptomatic. All adverse events resolved entirely when the drug was stopped. Progabide is an effective antispastic agent and its antispastic effect is not accompanied by increased motor weakness. The use of the drug, however, is associated with a high incidence of adverse events, which will likely limit progabide's therapeutic usefulness.

Author Affiliations
From the Mellen Center and Department of Neurology, Cleveland Clinic Foundation (Dr Rudick), the School of Nursing, University of Rochester (NY) School of Medicine and Dentistry (Ms Breton), and Lorex Pharmaceuticals, Skokie, Ill (Dr Krall).

Footnotes
Accepted for publication May 20, 1987.

Reprint requests to Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland OH 44106 (Dr Rudick).

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