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Modafinil to treat fatigue in amyotrophic lateral sclerosis: An open label pilot study

Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington

Michael D. Weiss, MD

Department of Neurology, University of Washington School of Medicine, Seattle, Washington

Jau-Shin Lou, MD, PhD

Department of Neurology, Oregon Health Sciences University, Portland, Oregon

Mark P. Jensen, PhD

Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington

R. Ted Abresch, MS

Department of Physical Medicine and Rehabilitation University of California, Davis, California

Tara K. Martin, MA

Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington

Thomas W. Hecht, MD

Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington

Jay J. Han, MD

Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington

Patrick Weydt, MD

Department of Neurology, University of Washington School of Medicine, Seattle, Washington

George H. Kraft, MD, MS

Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington

An open label trial of modafinil was conducted to determine whether it would be tolerated and effective in treating fatigue for people with amyotrophic lateral sclerosis (ALS). Fifteen patients with ALS were treated for two weeks with either 200 mg or 400 mg of modafinil. Reported side effects of the medication were mild and included diarrhea, headache, nervousness, and insomnia. Side effects did not result in any study dropouts. Following treatment, mean scores on the Fatigue Severity Scale (FSS) decreased from 51.3 (SD 9.2) to 42.8 (SD 10.2). On the Epworth Sleepiness Scale (ESS), mean scores decreased from 8.2 (SD 2.0) to 4.5 (SD 2.4). Reductions in both the FSS and the ESS were significant at p < 0.001. Mean scores on the self-report version of the Functional Independence Measure (FIM-SR) increased from 115.2 (SD 5.6) to 118.1 (SD 5.4), with p < 0.01. This pilot study suggests that modafinil is well-tolerated and may reduce symptoms of fatigue in ALS. Further blinded, controlled studies of modafinil in larger numbers of ALS patients are warranted.

Key Words: amyotrophic lateral sclerosis • modafinil • fatigue • motor neuron disease • functional independence measure

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