A drug used to treat some of the symptoms of the sleeping disorder narcolepsy also appears to help control fatigue in patients with multiple sclerosis.
Researchers found that a 200 milligram-per-day dose of the drug modafinil, sold under the brand name Provigil, successfully controlled fatigue in patients with MS, a disease that attacks the nervous system.
"About 70 percent of all MS patients suffer from fatigue," said Kottil Rammohan, an associate professor of neurology at Ohio State University. "It's one of the most disabling symptoms of MS." Other symptoms of MS include blurred vision, tremors and weakness, particularly in the legs. Rammohan will present study's findings on May 1 at the annual meeting of the American Academy of Neurology in San Diego.
Provigil is currently approved to treat excessive daytime sleepiness, which is one of the major symptoms of patients with narcolepsy.
During a nine-week trial, the researchers studied 72 patients with severe fatigue and MS. The patients received a placebo during the first two weeks and again during the final three weeks of the study. During weeks three and four, each patient received 200 milligrams of modafinil; during weeks five and six, the dosage was upped to 400 mg daily.
After each phase of treatment, the researchers asked each patient to evaluate his level of fatigue and sleepiness. Overall, patients reported significantly less fatigue when they took the 200 mg dose compared to the placebo. However, when patients took the 400 mg dose, some of them experienced side effects that "probably overshadowed any favorable effects on fatigue by the drug," Rammohan said.
In this study, the most common side effects of the 200 mg dosage were headaches (19 percent of patients); nervousness (14 percent); and loss of physical strength (12 percent). "None of the side effects reported by patients were serious, however," Rammohan said.
In addition to helping control fatigue, and unlike other sleep-suppressors, modafinil has little potential for abuse, according to Rammohan. "There's some stimulant effect with this drug," he said. "But modafinil targets select areas of the brain -- the areas presumably important to fatigue and to wakefulness. Stimulants such as Ritalin and amphetamines cause the whole brain to light up in terms of activity."
Rammohan conducted the study with Charles Pollak, D. Joanne Lynn and Haikady Nagaraja, all at Ohio State; and Jay Rosenberg and Andrew Blumenfeld, both with Kaiser Permanente in San Diego. This study was funded by a grant from the National Institutes of Health, and by Cephalon, Inc., the manufacturer of Provigil.
Contact: Kottil Rammohan, (cell phone for Monday, May 1, 2000 is 614-329-7556); 614-293-4964; Rammohan.2@osu.edu Written by Holly Wagner, 614-292-8310; Wagner.235@osu.edu
Editor's note: Pollak is a member of the Cephalon speakers bureau and also a paid consultant to Cephalon. Cephalon is the company that produces Provigil.