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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Christopher Levi
None provided
Christopher.Levi@health.nsw.gov.au


Miss Amy Jolly
+44 (0)1223 217 695
aj602@medschl.cam.ac.uk


Prof Hugh Markus
+44 (0)1223 586661
hsm32@medschl.cam.ac.uk


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Be Part of Research - Trial Details - Will the medication modafinil reduce post-stroke fatigue and improve quality of life of patients?
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Will the medication modafinil reduce post-stroke fatigue and improve quality of life of patients?

Recruiting

Open to: All Genders

Age: Adult

Cambridge

Medical Conditions

Stroke survivors suffering from severe fatigue

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The most common post-stroke symptom is ‘fatigue’, affecting up to 70% of stroke survivors. Stroke-related fatigue is 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. This study aims to confirm the previous study results, by testing if 200mg of modafinil taken daily for 56 days can alleviate stroke-related fatigue and improve the quality of life of patients 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's burden on the caregiver.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Jun 2018 31 Dec 2026

Participants will attend four study visits (screening, Day 0, 28 and 56) for trial assessments. Study participants 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.

Suitable patients will be identified by clinical staff working in the outpatient clinics in the Stroke Services at participating sites. The process will be aided by stroke research nurses and coordinators funded by Clinical Research Network (CRN). All research staff consenting patients will have valid GCP training. Patients meeting the inclusion criteria will be asked if they wish to participate.

Participant identification: Participants will be identified from the existing patient pools at each participating site. Stroke survivors who come into the hospital or are contacted over the phone for a follow-up will be asked if they are willing to be part of the research and are also experiencing severe fatigue. If so, their name and contact details will be recorded and passed on to a member of the research team who will approach the patient for screening and consent as well as provide detailed information about what the study involves to the participant. Patient eligibility screening will be conducted according to the protocol inclusion and exclusion criteria. Specifically, the screening requires a score of 60 or more on the MFI.

Given study participants are not eligible for enrolment till 3 months or longer following their stroke, sites participating in the study might approach their local stroke survivor registers for participants who are eligible & willing to participate in the study. e.g. bodies like the Stroke Association UK which maintain an online forum of stroke survivors who can potentially be contacted for research trials. Any proposed advertising materials will be reviewed and approved by the Ethics Committee before being implemented.


Adult stroke survivors whose stroke occurred at least three months before 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

You can take part if:



You may not be able to take part if:


1. An active, symptomatic or untreated anxiety disorder who, based on the clinical judgement of the investigator, could be prone to an exacerbation of anxiety with the use of modafinil (Note: Subjects with well-controlled anxiety who are on medication are eligible for consideration for inclusion in the trial)2. An active, symptomatic or untreated depression who, based on the clinical judgement of the investigator could be prone to an exacerbation of depression or the development of agitation (Note: Subjects with well-controlled depression who are stable and/or have been on antidepressant medication for at least 6 months are eligible for consideration for inclusion in the trial)3. Pre-existing dementia or other neuropsychiatric disease 4. Other diagnoses with fatigue as a known symptom e.g. chronic fatigue syndrome, multiple sclerosis, narcolepsy5. Current or past drug abuse6. Known contraindication to treatment with modafinil7. Known active malignancy, intracranial tumour, subdural or epidural hematoma8. Severe renal or hepatic impairment (GFR <15mL/min)9. Unstable or poorly controlled epilepsy where the investigator is concerned about the potential for drug interactions. Refer to appendix 2 for specific medication guidance10. Benzodiazepines or other hypno-sedative drugs which may interact with modafinil as per specific medication guidance provided in appendix 211. Clinical suspicion of sleep apnoea. If the investigator suspects on clinical grounds, that fatigue is related to sleep apnoea, an Epworth Sleepiness Scale must be undertaken. If the score is >10, overnight pulse oximetry monitoring or a sleep study must be undertaken to exclude sleep apnoea 12. Participant is receiving immunosuppressive therapy or has a known immunodeficiency state, e.g., HIV13. Pregnant or breastfeeding women. Women of childbearing potential will need to have a negative pregnancy test at screening and should agree to using an acceptable barrier form of birth control. The effectiveness of steroidal contraceptives (contraceptive pill, implants, intrauterine devices (IUDs) or patches, etc.) may be impaired due to induction of CYP3A4/5 by modafinil. Alternative or concomitant methods of contraception are recommended for patients treated with modafinil. Acceptable methods of contraception should continue to be used for at least two months after ingestion of the final study dose.14. Are likely unable to complete protocol requirements due to logistical factors such as inadequate Information and communication technology (ICT) capability or inability to attend for face-to-face follow-up, as assessed and confirmed by the local investigator


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Addenbrookes Hospital
    Hills Road
    Cambridge
    CB2 0QQ

There will be no clear or definite benefit to participation in this research. However, participation will contribute to the research efforts to discover treatments that work for stroke-related fatigue. Medical treatments often cause side effects. The participant may have none, some or all of the effects listed in the participant information sheet, and they may be mild, moderate or severe. If they have any of these side effects or are worried about them, they should talk with their study doctor. The study doctor will also be looking out for side effects.

Prof Hugh Markus
+44 (0)1223 586661
hsm32@medschl.cam.ac.uk


Miss Amy Jolly
+44 (0)1223 217 695
aj602@medschl.cam.ac.uk


Prof Christopher Levi
None provided
Christopher.Levi@health.nsw.gov.au



The study is sponsored by University of Newcastle Australia and funded by Medical Research Future Fund.



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Read full details for Trial ID: ISRCTN13106662

Or CPMS 55358

Last updated 09 June 2025

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