Modafinil in debilitating fatigue after stroke

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000350527
• Date of registration: 17/04/2015
• Prospective Registration: Yes
• Primary sponsor: Hunter-New England Local Health District
• Public title: Modafinil in debilitating fatigue after stroke
• Scientific title: For survivors of stroke/TIA experiencing self-reported persistent fatigue, will modafinil be more effective than placebo for reducing self-reported fatigue levels and increasing physical activity levels
• Date of first enrolment: 16/06/2015
• Target sample size: 36
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000350527.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Andrew Bivard

• Name: Dr Andrew Bivard

Key inclusion & exclusion criteria

Inclusion criteria: 1: have suffered an ischaemic stroke or TIA at least 3 months ago
2: have persistent self-reported fatigue with MFI-20 score of 12 or more
3: modified Rankin Score (mRS) of 3 or less
4: can speak reasonable English, understand instructions and be able to complete tests and questionnaires on their own or with minimal support
5: able to give informed consent

Exclusion criteria: 1: pre-existing depression, dementia or other neuropsychiatric disease
2: other diagnoses with fatigue as a known symptom e.g. chronic fatigue syndrome, multiple sclerosis
3: stroke induced by trauma, infection or surgery
4: current or past drug abuse
5: known contraindication to treatment with modafinil
6: known active malignancy, any intracranial tumor, subdural or epidural hematoma
7: known contraindications to MRI scanning e.g. claustrophobia, pacemaker or other implants
8: renal or hepatic impairment
9: use of benzodiazepines or antiepileptic drugs
10: patients on immunosuppression or known immunodeficiency state e.g. HIV


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Stroke - Ischaemic

Stroke;Transient Ischaemic Attack;
Stroke
Transient Ischaemic Attack

Intervention(s)

Modafinil (a wakefulness-promoting agent) 200mg/day oral for 6 weeks, with a 2 week washout period between active drug and placebo.
Monitoring adherence will be through drug return.

Primary Outcome(s)

Changes in physical activity as determined by the use of wearable monitoring devices (Fitbit HR) which the participant is required to wear during the entire study period. [At the end of each 6-week treatment arm.]

Self-reported fatigue as assessed on the Multi-dimensional Fatigue Inventory (MFI-20). [At the end of each 6-week treatment arm.]

Secondary Outcome(s)

Stroke specific quality of life (SSQOL) score.[At the end of each 6-week treatment arm.]

Cognition assessed with the Montreal Cognitive Assessment (MoCA)[At the end of each 6-week treatment arm.]

At the end of each 6-week treatment arm.[At the end of each 6-week treatment arm.]

Mood as assessed by the depression, anxiety and stress scale (DASS 42).[At the end of each 6-week treatment arm.]

Whole-brain cerebral blood flow as measure by MRI ASL.[At the end of each 6-week treatment arm.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Hunter Medical Research Institute

Secondary Sponsor(s)

Hunter Medical Research Institute

Ethics review

Status: Approved
Approval date:
Contact:

Hunter New England HREC