MIDAS2
Research type
Research Study
Full title
Modafinil In Debilitating Fatigue After Stroke 2 (MIDAS2 Part I and MIDAS2 Part II tele health)
IRAS ID
1004119
Contact name
Hugh Markus
Contact email
Sponsor organisation
The University of Newcastle, Australia
Eudract number
2019-001448-22
Research summary
The most common post-stroke symptom is ‘fatigue’, affecting up to 70% of stroke survivors. Stroke related fatigue has been shown to be a predictor of needing help in activities of daily living, and is also associated with poor quality of life, inability to return to work and increased mortality within the first year of stroke. Most importantly, there are currently no therapies available for stroke survivors to help manage their fatigue.
Modafinil is a medication to treat sleepiness due to narcolepsy, shift work sleep disorder, or obstructive sleep apnoea. A previous study tested modafinil in stroke survivors with severe persisting fatigue and found that 6 weeks of modafinil treatment reduced fatigue and improved the quality of life for the participants.
The aim of this double-blind randomised controlled trial is to confirm the previous study results, by testing if 200mg of modafinil taken daily for 56 days can alleviate stroke related fatigue and improve quality of life of patient and if modafinil is safe in a large population of stroke survivors. Additionally, the study also aims to perform a short assessment of the participant’s caregiver/carer to identify if modafinil treatment taken by the participant reduces the carer burden on the caregiver.
The study will recruit stroke survivors whose stroke occurred at least three months prior to study entry, who self-report significant fatigue affecting their quality of life, scoring over 60 on the Multidimensional Fatigue Inventory and who have no contraindication to modafinil. Participants will attend four study visits (screening, Day 0, 28 and 56) for trial assessments. Study participant will be randomly assigned to either Modafinil (200mg daily) or Placebo Group. The treatment will last 56 days. Caregivers will also be asked to complete questionnaires at each study visit.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0191
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion