BACKGROUND AND PURPOSE: Poststroke fatigue is common and reduces quality of life. Current evidence for intervention is limited, and this is the first placebo-controlled trial to investigate treatment of poststroke fatigue with the wakefulness promoting drug @entity2728 . METHODS: The trial was randomized, double-blinded, and placebo-controlled. @entity1 were treated with 400-mg @entity2728 or placebo for 90 days. Assessments were done at inclusion, 30, 90, and 180 days. The primary end point was fatigue at 90 days measured by the Multidimensional Fatigue Inventory-20 general fatigue domain. Secondary end points included the Fatigue Severity Scale, the Montreal Cognitive Assessment, the modified Rankin Scale and the @entity64 -specific quality of Life questionnaire. Adult @entity1 with a recent @entity64 achieving a score of >= 12 on the Multidimensional Fatigue Inventory-20 general fatigue domain were consecutively included. Exclusion criteria were severe @entity73 and contraindications for @entity2728 treatment. RESULTS: One thousand one hundred twenty-one @entity1 with @entity64 were screened and 41 @entity1 included, 21 received @entity2728 . The primary end point, the Multidimensional Fatigue Inventory-20 general fatigue score, did not differ between groups. @entity1 in the @entity2728 group obtained better scores on the Fatigue Severity Scale (P=0.02) and in some subscales of the @entity64 -specific quality of life questionnaire (0.001<P<0.05), which were secondary outcomes. No serious adverse reactions were observed and there was no difference in blood pressure between groups. CONCLUSIONS: There were no significant differences between the 2 groups with regard to the primary end point. There were secondary significant outcomes that should be explored in future trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01800097.

XXXX May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke', 'Stroke'] @entity2728 :: ('MESH:C048833', 'Chemical') :: ['modafinil'] @entity73 :: ('MESH:D003072', 'Disease') :: ['cognitive disabilities']
@entity2728 :: (MESH:C048833,Chemical) :: ['Modafinil']
