ACTRN12618000602224RecruitingPhase 3
A Phase III, Multicentre, Prospective, Randomised, Placebo-controlled, Double-blind,Parallel group study to evaluate the effect of Modafinil on Debilitating Fatigue in Stroke Survivors
The Florey Institute of Neuroscience and Mental Health (The Florey)0 sites300 target enrollmentStarted: April 18, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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
- •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
Investigators
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