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Published on: June 6, 2025
Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial
Mai Bang Poulsen1, Bodil Damgaard2, Bo Zerahn2
1Departments of Neurology (M.B.P., K.O., R.S.R.), Radiology (B.D.), and Clinical Physiology (B.Z.), Herlev University Hospital, Herlev, Denmark; and Department of Radiology, Hilleroed University Hospital, Hilleroed, Denmark (B.D.). maibang@gmail.com.
Modafinil did not significantly improve general fatigue in stroke survivors. However, secondary outcomes showed improvements in fatigue severity and quality of life, warranting further investigation.
Area of Science:
- Neurology
- Clinical Trials
- Pharmacology
Background:
- Poststroke fatigue is a prevalent condition impacting patient quality of life.
- Limited evidence exists for effective interventions against poststroke fatigue.
- This study represents the first placebo-controlled trial investigating modafinil for poststroke fatigue.
Purpose of the Study:
- To evaluate the efficacy of modafinil in treating fatigue in adult patients following a recent stroke.
- To assess the impact of modafinil on fatigue severity, cognitive function, and quality of life poststroke.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- 41 adult stroke patients with significant fatigue were randomized to receive either 400-mg modafinil or placebo for 90 days.
- Primary endpoint was fatigue measured by the Multidimensional Fatigue Inventory-20; secondary endpoints included Fatigue Severity Scale and quality of life questionnaires.
Main Results:
- No significant difference was observed in the primary endpoint (Multidimensional Fatigue Inventory-20 general fatigue score) between the modafinil and placebo groups.
- Patients receiving modafinil showed statistically significant improvements in the Fatigue Severity Scale and certain aspects of the Stroke-Specific Quality of Life questionnaire.
- No serious adverse events or significant differences in blood pressure were reported between the groups.
Conclusions:
- Modafinil did not demonstrate a significant effect on the primary measure of general fatigue in poststroke patients.
- Secondary outcomes suggest potential benefits of modafinil on fatigue severity and quality of life, meriting further research.
- Further trials are recommended to explore these secondary findings and optimize treatment strategies for poststroke fatigue.

