Related Experiment Video
Updated: Jul 14, 2026
The Treadmill Fatigue Test: A Simple, High-throughput Assay of Fatigue-like Behavior for the Mouse
Published on: May 31, 2016
Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial
O M Vasconcelos1, O A Prokhorenko, M K Salajegheh
1Department of Neurology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA. ovasconcelos@usuhs.mil
Objective:
To determine if modafinil can improve fatigue in patients with post-polio syndrome.
Methods:
We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects.
Results:
Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments.
Conclusion:
Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.
Insights
Modafinil did not improve fatigue or quality of life in patients with post-polio syndrome. This randomized trial found no significant difference compared to placebo for fatigue symptoms.
Area of Science:
- Neurology
- Clinical Trials
- Pharmacology
Background:
- Post-polio syndrome (PPS) is a neurological condition causing significant fatigue.
- Fatigue in PPS negatively impacts patients' quality of life.
- Effective treatments for PPS-related fatigue are limited.
Purpose of the Study:
- To evaluate the efficacy of modafinil in alleviating fatigue in patients with post-polio syndrome.
- To assess modafinil's impact on health-related quality of life in the PPS population.
Main Methods:
- A randomized, placebo-controlled crossover trial was conducted.
- Patients received modafinil (400 mg/day) or placebo for 6-week periods.
- Fatigue Severity Scale, Visual Analog Scale for Fatigue, and Fatigue Impact Scale were primary outcome measures.
Main Results:
- Thirty-three patients completed the trial; modafinil was safe and well-tolerated.
- No statistically significant difference in fatigue levels was observed between modafinil and placebo groups.
- Modafinil did not improve health-related quality of life compared to placebo.
Conclusions:
- Modafinil is not superior to placebo for treating fatigue in post-polio syndrome.
- Current outcome measures suggest modafinil does not alleviate fatigue or improve quality of life in PPS patients.
