Stroke survivors suffering from severe fatigue Nervous System Diseases
Conditions
Interventions
Modafinil: 200mg taken once a day for 56 days followed by an optional open-label non-randomised observational phase for 10 months. Route: oral tablet. Time of administration
Modafinil is ideally to be taken with breakfast. Treatment adherence will be monitored by drug tablet return.
Matching placebo: 200mg physically identical to modafinil tablets taken once a day for at
ideally to be taken with breakfast. Treatment adherence will be monitored by drug tablet return.
Study participants are follow-up for 12 months
Randomisation will be based on a 1:1 allocation ratio
Sponsors
University of Newcastle Australia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older 2. Have suffered a stroke (ischaemic / Haemorrhagic) at least 3 months ago 3. Have persistent self-reported fatigue with an MFI score of 60 or more 4. Modified Rankin Score (mRS) of 3 or less 5. Can speak reasonable English, understand instructions and be able to complete tests and questionnaires on their own or with minimal support 6. Able to give informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study-related procedures
Exclusion criteria
Exclusion criteria: 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, narcolepsy 5. Current or past drug abuse 6. Known contraindication to treatment with modafinil 7. Known active malignancy, intracranial tumour, subdural or epidural hematoma 8. Severe renal or hepatic impairment (GFR 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., HIV 13. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported quality of life measured using the 36-Item Short Form Survey (SF-36) at 56 days post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using the 36-Item Short Form Survey (SF-36) at baseline, 28 days, 56 days and 12 months 2. Fatigue is measured using the Multidimensional Fatigue Inventory (MFI) at baseline, 28 days, 56 days and 12 months 3. Cognitive performance is measured using the Montreal Cognitive Assessment (MoCA) and Trail Making A and B test at baseline, 28 days, 56 days and 12 months 4. Depression, anxiety and stress is measured using a 42-item self-reported score Depressive Anxiety and Stress Scale (DASS 42) at baseline, 28 days, 56 days and 12 months 5. Generic health status is measured using the EuroQol five dimensions questionnaire (EQ-5D) at baseline, 28 days, 56 days and 12 months 6. Carer burden and concerns is measured using the Oberst Caregiving Burden Scale (OCBS) and Caregiver Strain Index (CSI) at baseline, 28 days, 56 days and 12 months 7. Degree of disability in patients who have had a stroke is measured using the Modified Ranking Scale (mRS) at baseline, 28 days, 56 days and 12 months 8. Fatigue is measured using a 9-item self-administered Fatigue Severity Scale (FSS) at baseline, 28 days, 56 days and 12 months 9. Safety is measured using the number of serious adverse events (SAEs), and the number of study drug related rash complications at baseline, 28 days, 56 days, 3 months, 6 months and 12 months | — |
Countries
Australia, England, United Kingdom
Contacts
Public ContactAmy Jolly
Outcome results
None listed