Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.
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.


CONCLUSIONS
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.
Vasconcelos
O M
OM
Department of Neurology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA. ovasconcelos@usuhs.mil
Prokhorenko
O A
OA
Salajegheh
M K
MK
Kelley
K F
KF
Livornese
K
K
Olsen
C H
CH
Vo
A H
AH
Dalakas
M C
MC
Halstead
L S
LS
Jabbari
B
B
Campbell
W W
WW
D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D015990:Placebo Effect; D016262:Postpoliomyelitis Syndrome / Q000150:complications*; D011788:Quality of Life; D012720:Severity of Illness Index; D017211:Treatment Failure
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil