title: Modafinil to treat fatigue in amyotrophic lateral sclerosis: an open label pilot study.
abstract: 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.
authors.affiliation: Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Carter
authors.forename: Michael D
authors.initials: MD
authors.lastname: Weiss
authors.forename: Jau-Shin
authors.initials: JS
authors.lastname: Lou
authors.forename: Mark P
authors.initials: MP
authors.lastname: Jensen
authors.forename: R Ted
authors.initials: RT
authors.lastname: Abresch
authors.forename: Tara K
authors.initials: TK
authors.lastname: Martin
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Hecht
authors.forename: Jay J
authors.initials: JJ
authors.lastname: Han
authors.forename: Patrick
authors.initials: P
authors.lastname: Weydt
authors.forename: George H
authors.initials: GH
authors.lastname: Kraft
mesh_terms: D000690:Amyotrophic Lateral Sclerosis / Q000150:complications* / Q000188:drug therapy; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D000077408:Modafinil; D010865:Pilot Projects; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil