May 2, 2000
SAN DIEGO, CA (Reuters Health) - A medication approved to treat narcolepsy may help improve fatigue in patients with multiple sclerosis (MS), according to study results reported here this weekend at the 52nd annual meeting of the American Academy of Neurology.
Dr. Kottil W. Rammohan, of Ohio State University in Columbus, and associates there and at Kaiser Permanente Medical Center, San Diego, California, treated 72 patients with a single daily dose of placebo for 2 weeks, modafinil 200 mg/day plus placebo during weeks 3 and 4, modafinil 400 mg/day during weeks 5 and 6, and placebo during weeks 7 through 9.
Participants in the trial ranged from 18 to 65 years of age and had a stable disability score of 6 or less on the Kurtzke Expanded Disability Severity Scale (EDSS) and a mean score of 4 or higher on the Fatigue Severity Scale (FSS). Most had failed prior treatment with the drugs amantadine and pemoline.
The trial excluded patients with narcolepsy, sleep apnea, or clinically significant major disease and patients who had recently used medications likely to cause fatigue.
The efficacy of treatment was evaluated by patients who were blinded to treatment. Results showed that modafinil 200 mg/d significantly improved fatigue on the FSS, the Visual Analogue Fatigue Scale, and the Modified Impact Fatigue Scale. Overall, 85% of patients were able to distinguish the active medication from placebo solely on the basis of their improvement in fatigue.
"More than 75% of MS patients have chronic disabling fatigue irrespective of the severity of their MS, and current treatments are for the most part ineffective," Dr. Rammohan said. "The findings suggest that modafinil may be superior in terms of effectiveness, safety and tolerability, and lack of potential for abuse."
The most common side effects were headache, nervousness and asthenia, which occurred more frequently with the 400-mg dose. Only four patients withdrew from the study because of adverse effects related to modafinil. Patients said that they preferred the 200-mg dose because it was better tolerated.
Dr. Rammohan said that studies are planned that will examine the use
of modafinil in chronic fatigue syndrome and fatigue associated with chemotherapy.