http://stroke.ahajournals.org/content/early/2017/04/12/STROKEAHA.116.016293?papetoc=
Abstract
Background and Purpose—This
study aimed to assess the efficacy of modafinil, a
wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months
after stroke. We hypothesized that 200 mg of modafinil daily for 6
weeks would result in reduced symptoms of fatigue compared with placebo.
Methods—This
single-center phase 2 trial used a randomized, double-blind,
placebo-controlled, crossover design. The key inclusion criterion was a
multidimensional fatigue inventory score of ≥60. Patients were
randomized to either modafinil or placebo for 6 weeks of therapy, then
after a 1 week washout period swapped treatment arms for a second 6
weeks of therapy. The primary outcome was the multidimensional fatigue
inventory; secondary outcomes included the Montreal cognitive
assessment, the Depression, Anxiety, and Stress Scale (DASS), and the
Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional
fatigue inventory is a self-administered questionnaire with a range of 0
to 100. Treatment efficacy was assessed using linear regression by
estimating within-person, baseline-adjusted differences in mean outcomes
after therapy. This trial was registered with the Australian New
Zealand Clinical Trials Registry (ACTRN12615000350527).
Results—A
total of 232 stroke survivors were screened and 36 were randomized.
Participants receiving modafinil reported a significant decrease in
fatigue (multidimensional fatigue inventory, −7.38; 95% CI, −21.76 to
−2.99; P<0.001) and improved quality of life (SSQoL, 11.81; 95% CI, 2.31 to 21.31; P=0.0148)
compared with placebo. Montreal cognitive assessment and DASS were not
significantly improved with modafinil therapy during the study period (P>0.05).
Conclusions—Stroke
survivors with nonresolving fatigue reported reduced fatigue and
improved quality of life after taking 200 mg daily treatment with
modafinil.
Clinical Trial Registration—URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527.
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