Study results reported in the March 2009 issue of Muscle & Nerve indicate that modafinil (marketed under the brand name Provigil) "may be a promising intervention for fatigue in ALS (amyotrophic lateral sclerosis) patients." Fatigue and daytime sleepiness often accompany this disease.
Hiroshi Mitsumoto, director of the Eleanor and Lou Gehrig MDA/ALS Research Center at Columbia University Medical Center in New York, where the study was based, received MDA support to conduct it.
|Although the modafinil study was small, Hiroshi Mitsumoto says results are "encouraging" for people with ALS who experience extreme fatigue.
Modafinil has U.S. Food and Drug Administration (FDA) approval for the treatment of adults with excessive sleepiness related to the neurologic disorder narcolepsy, obstructive sleep apnea syndrome and shift-work sleep disorder.
The trial found 19 of 25 (76 percent) of study participants randomly assigned to receive modafinil for four weeks were judged to be "responders" to the medication. Only one of seven (14 percent) assigned to a placebo (inert, lookalike substance) was judged to be a responder.
Participants’ responses to the drug were assessed on the Clinical Global Impressions Improvement Scale, a standardized assessment tool that uses scores from 1 (very much improved) to 7 (very much worse), as compared to baseline. This global assessment is based on all available data, including the judgment of the clinician and self-reports of the patients.
Although Mitsumoto calls study results “encouraging,” he cautions that the study was small and a larger one is needed to confirm these results.
An earlier, 15-person study, conducted by Greg Carter and Michael Weiss, co-directors of the MDA/ALS Center at the University of Washington-Seattle, had shown modafinil was well tolerated by ALS patients and that it improved measures of daytime sleepiness. (See "Modafinil May Help With Staying Awake" ALS Newsmagazine, February-March 2005.)