Modafinil In Debilitating Fatigue After Stroke 2(MIDAS 2)

Phase 3

Recruiting

• Conditions: Post Stroke Fatigue; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12618000602224
• Lead Sponsor: The Florey Institute of Neuroscience and Mental Health (The Florey)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-18
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Participant:
•18 years of age or older
•have suffered a stroke (ischaemic/ Haemorrhagic) at least 3 months ago
•have persistent self-reported fatigue with MFI score of 60 or more
•modified Rankin Score (mRS) of 3 or less
•can speak reasonable English, understand instructions and be able to complete tests and questionnaires on their own or with minimal support
•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

Caregiver:
•have the consent of the study participant for whom they care for, to take part in the research
•meets the definition of a ‘caregiver’ to participate in the research. They must be a reliable and capable person, who either lives in the same household with the participant or interacts with the participant at least 10 hours per week and will be available to attend all clinic visits with them in person.
•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

•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)

• 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)

• pre-existing dementia or other neuropsychiatric disease

• other diagnoses with fatigue as a known symptom e.g. chronic
fatigue syndrome, multiple sclerosis, narcolepsy

• current or past drug abuse

• known contraindication to treatment with modafinil

• known active malignancy, intracranial tumour, subdural or
epidural hematoma

• severe renal or hepatic impairment (GFR <15mL/min)

• Unstable or poorly controlled epilepsy where the investigator is
concerned about the potential for drug interactions.

• benzodiazepines or other hypnosedative drugs which may
interact with modafinil as per specific medication guidance

• 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.

• participant is receiving immunosuppressive therapy or has a
known immunodeficiency state, e.g., HIV.

• pregnant or breastfeeding women. Women of child bearing
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Quality of life of participants on Modanifil compared to placebo assessed by an increase of 10 or more points on the self-reported quality of life using the 36-item Short Form Survey (SF-36). [Assessments will be completed at Baseline, Day 28, Day 56 (primary endpoint) and Month 12 (optional). <br>It is optional for the participants to participate in the open label sub study. Participants will be consented to this sub study. If consent is obtained and participant is recruited to the sub study, the month 12 follow-up will be completed. ]