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Trial registered on ANZCTR
Registration number
ACTRN12615000350527
Ethics application status
Approved
Date submitted
27/03/2015
Date registered
17/04/2015
Date last updated
31/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Modafinil in debilitating fatigue after stroke
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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
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Secondary ID [1]
286435
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
MIDAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
294604
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Transient Ischaemic Attack
294692
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Condition category
Condition code
Stroke
294907
294907
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
291513
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Treatment: Drugs
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Comparator / control treatment
Placebo consisting of a rice-powder capsule.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Self-reported fatigue as assessed on the Multi-dimensional Fatigue Inventory (MFI-20).
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Assessment method [1]
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Timepoint [1]
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At the end of each 6-week treatment arm.
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Primary outcome [2]
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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.
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Assessment method [2]
294740
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Timepoint [2]
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At the end of each 6-week treatment arm.
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Secondary outcome [1]
313825
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At the end of each 6-week treatment arm.
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Assessment method [1]
313825
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Timepoint [1]
313825
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At the end of each 6-week treatment arm.
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Secondary outcome [2]
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Cognition assessed with the Montreal Cognitive Assessment (MoCA)
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Assessment method [2]
313970
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Timepoint [2]
313970
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At the end of each 6-week treatment arm.
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Secondary outcome [3]
313971
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Mood as assessed by the depression, anxiety and stress scale (DASS 42).
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Assessment method [3]
313971
0
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Timepoint [3]
313971
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At the end of each 6-week treatment arm.
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Secondary outcome [4]
313972
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Stroke specific quality of life (SSQOL) score.
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Assessment method [4]
313972
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Timepoint [4]
313972
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At the end of each 6-week treatment arm.
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Secondary outcome [5]
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Whole-brain cerebral blood flow as measure by MRI ASL.
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Assessment method [5]
313973
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Timepoint [5]
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At the end of each 6-week treatment arm.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment first or placebo first will only occur after the patient has been enrolled and will be conducted by central randomisation conducted off-site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2015
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Actual
16/06/2015
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Date of last participant enrolment
Anticipated
1/01/2018
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Actual
30/05/2016
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Date of last data collection
Anticipated
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Actual
6/09/2016
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Sample size
Target
36
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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John Hunter Hospital Royal Newcastle Centre - New Lambton
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Recruitment postcode(s) [1]
9400
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2305 - New Lambton Heights
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Funding & Sponsors
Funding source category [1]
291005
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Other Collaborative groups
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Name [1]
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Hunter Medical Research Institute
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Address [1]
291005
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1 Kookaburra Cct, New Lambton Heights, NSW, 2305
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Country [1]
291005
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Australia
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Primary sponsor type
Government body
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Name
Hunter-New England Local Health District
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Address
Lookout Rd, New Lambton Heights, NSW 2305
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Country
Australia
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Secondary sponsor category [1]
289683
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Other Collaborative groups
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Name [1]
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Hunter Medical Research Institute
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Address [1]
289683
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1 Kookaburra Cct
New Lambton Heights, NSW, 2305
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Country [1]
289683
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Hunter New England HREC
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Ethics committee address [1]
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John Hunter Hospital Locked Bag 1 Lookout Road NEW LAMBTON NSW 2305
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
292591
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27/03/2015
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Approval date [1]
292591
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05/06/2015
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Ethics approval number [1]
292591
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15/04/15 3.02
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Summary
Brief summary
Debilitating Fatigue is a common complaint in survivors of stroke and transient ischaemic attack (TIA) and can persist for years after the acute event, causing lack of physical activity and participation in rehabilitation and socialisation. Currently there are no pharmaceutical agents approved for the treatment of this fatigue. Modafinil has been shown to reduce fatigue in patients suffering other neurological conditions such as MS and Parkinson's disease, and to improve cognition and memory. This study will aim to measure the efficacy of modafinil in survivors of stroke and TIA experiencing self-reported fatigue.
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Trial website
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Trial related presentations / publications
MIDAS (Modafinil in Debilitating Fatigue After Stroke) Bivard, A. et al 2017 Stroke Vol 48 pp1293
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Public notes
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Contacts
Principal investigator
Name
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Prof Christopher Levi
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Address
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John Hunter Hospital
Lookout Rd, New Lambton Heights, NSW, 2305
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Country
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Australia
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Phone
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+61 02 49 855593
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Fax
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+61 02 49 213488
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Email
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[email protected]
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Contact person for public queries
Name
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Andrew Bivard
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Address
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Hunter Medical Research Institute
1 Kookaburra Cct,
New Lambton Heights, NSW, 2305
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Country
56131
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Australia
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Phone
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+61 02 40420315
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Fax
56131
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Email
56131
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[email protected]
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Contact person for scientific queries
Name
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Andrew Bivard
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Address
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Hunter Medical Research Institute
1 Kookaburra Cct,
New Lambton Heights, NSW, 2305
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Country
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Australia
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Phone
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+61 02 40420315
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Fax
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Email
56132
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Modafinil In Debilitating fatigue After Stroke (MIDAS): Study protocol for a randomised, double-blinded, placebo-controlled, crossover trial.
2016
https://dx.doi.org/10.1186/s13063-016-1537-4
Embase
MIDAS (Modafinil in Debilitating Fatigue after Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.
2017
https://dx.doi.org/10.1161/STROKEAHA.116.016293
Embase
Short- and long-term efficacy of modafinil at improving quality of life in stroke survivors: A post hoc sub study of the modafinil in debilitating fatigue after stroke trial.
2018
https://dx.doi.org/10.3389/fneur.2018.00269
Embase
Predicting modafinil-treatment response in poststroke fatigue using brain morphometry and functional connectivity.
2019
https://dx.doi.org/10.1161/STROKEAHA.118.023813
N.B. These documents automatically identified may not have been verified by the study sponsor.
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