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Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study.
B Stankoff1, E Waubant, C Confavreux
1Fédération de Neurologie, Hôpital de la Salpêtrière, AP-HP, Paris, France. bruno.stankoff@psl.ap-hop-paris.fr
Neurology
|April 13, 2005
Summary
Modafinil did not improve fatigue in multiple sclerosis (MS) patients compared to placebo. The wakefulness-promoting agent showed no significant benefits on the Modified Fatigue Impact Scale (MFIS) in this study.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Fatigue is a common and disabling symptom in multiple sclerosis (MS).
- Wakefulness-promoting agents are sometimes used to manage fatigue, but their efficacy in MS is not well-established.
Purpose of the Study:
- To evaluate the efficacy of modafinil in reducing fatigue in patients diagnosed with multiple sclerosis (MS).
Main Methods:
- A 5-week, randomized, double-blind, placebo-controlled study involving 115 MS patients with significant fatigue (MFIS score ≥ 45).
- Patients received either modafinil (200-400 mg/day) or a placebo, with the primary outcome being the change in MFIS score at 35 days.
Main Results:
- Both modafinil and placebo groups showed improvements in MFIS scores from baseline to day 35.
- No statistically significant difference in fatigue improvement was observed between the modafinil and placebo groups.
- Modafinil was generally well-tolerated with no major safety concerns identified.
Conclusions:
- Modafinil did not demonstrate a significant benefit over placebo in alleviating fatigue in patients with multiple sclerosis.
- Further research may be needed to explore other therapeutic strategies for MS-related fatigue.