Modafinil in debilitating fatigue after stroke 2 (research)

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The Modafinil In Debilitating Fatigue After Stroke 2 (MIDAS 2) study is a phase 3, placebo-controlled, multicentre trial of whether the medication modafinil improves quality of live by relieving severe and persistent fatigue after stroke.

Our researchers are seeking community-dwelling survivors of stroke, who had a stroke more than 3 months ago, and who are experiencing severe, ongoing fatigue that is affecting their quality of life.

After screening for eligibility, participants will be randomised to receive either 200 mg of modafinil, or a physically identical placebo, daily for 56 days.

Participants and study staff will all be blinded, in that they will not know who is receiving modafinil and who is receiving the placebo. Unblinding will only be done for analysis after the study is complete, or if there is an adverse event.

During the study, participants will be required to attend the clinic or study centre at day 28 (+/- 4 days, time point 1) and day 56 (+/- 4 days, time point 2) after joining the study. During these visits, participants will be required to undergo study assessments that will take up to an hour to perform.

Caregivers of the participants will also be given the option to participate in the MIDAS2 study and provide information in their capacity as a carer.

Trial locations:

  • John Hunter Hospital (NSW),
  • Liverpool Hospital (NSW),
  • Hornsby Ku Ring Gal Hospital (NSW)
  • Royal Prince Alfred Hospital (NSW)
  • The Royal Melbourne Hospital (VIC)
  • Sunshine Hospital and Footscray (VIC)
  • Box Hill Hospital (VIC)
  • The Perron Institute for Neurological and Translational Science (WA)
  • Royal Adelaide Hospital (SA)

Contact:

NSW, VIC and SA: Amy MacDonald via email amy.mcdonald@mh.org.au
WA only: Claire Tucak on 08 6457 0200, or email claire.tucak@perron.uwa.edu.au