Trial Review

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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
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
Secondary ID [1] 286435 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MIDAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 294604 0
Transient Ischaemic Attack 294692 0
Condition category
Condition code
Stroke 294907 294907 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291513 0
Treatment: Drugs
Comparator / control treatment
Placebo consisting of a rice-powder capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 294663 0
Self-reported fatigue as assessed on the Multi-dimensional Fatigue Inventory (MFI-20).
Timepoint [1] 294663 0
At the end of each 6-week treatment arm.
Primary outcome [2] 294740 0
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.
Timepoint [2] 294740 0
At the end of each 6-week treatment arm.
Secondary outcome [1] 313825 0
At the end of each 6-week treatment arm.
Timepoint [1] 313825 0
At the end of each 6-week treatment arm.
Secondary outcome [2] 313970 0
Cognition assessed with the Montreal Cognitive Assessment (MoCA)
Timepoint [2] 313970 0
At the end of each 6-week treatment arm.
Secondary outcome [3] 313971 0
Mood as assessed by the depression, anxiety and stress scale (DASS 42).
Timepoint [3] 313971 0
At the end of each 6-week treatment arm.
Secondary outcome [4] 313972 0
Stroke specific quality of life (SSQOL) score.
Timepoint [4] 313972 0
At the end of each 6-week treatment arm.
Secondary outcome [5] 313973 0
Whole-brain cerebral blood flow as measure by MRI ASL.
Timepoint [5] 313973 0
At the end of each 6-week treatment arm.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2015
Actual
16/06/2015
Date of last participant enrolment
Anticipated
1/01/2018
Actual
30/05/2016
Date of last data collection
Anticipated
Actual
6/09/2016
Sample size
Target
36
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3616 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 9400 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 291005 0
Other Collaborative groups
Name [1] 291005 0
Hunter Medical Research Institute
Country [1] 291005 0
Australia
Primary sponsor type
Government body
Name
Hunter-New England Local Health District
Address
Lookout Rd, New Lambton Heights, NSW 2305
Country
Australia
Secondary sponsor category [1] 289683 0
Other Collaborative groups
Name [1] 289683 0
Hunter Medical Research Institute
Address [1] 289683 0
1 Kookaburra Cct
New Lambton Heights, NSW, 2305
Country [1] 289683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292591 0
Hunter New England HREC
Ethics committee address [1] 292591 0
John Hunter Hospital
Locked Bag 1 Lookout Road NEW LAMBTON NSW 2305
Ethics committee country [1] 292591 0
Australia
Date submitted for ethics approval [1] 292591 0
27/03/2015
Approval date [1] 292591 0
05/06/2015
Ethics approval number [1] 292591 0
15/04/15 3.02

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.
Trial website
Trial related presentations / publications
MIDAS (Modafinil in Debilitating Fatigue After Stroke)
Bivard, A. et al 2017
Stroke Vol 48 pp1293
Public notes

Contacts
Principal investigator
Name 56130 0
Prof Christopher Levi
Address 56130 0
John Hunter Hospital
Lookout Rd, New Lambton Heights, NSW, 2305
Country 56130 0
Australia
Phone 56130 0
+61 02 49 855593
Fax 56130 0
+61 02 49 213488
Email 56130 0
[email protected]
Contact person for public queries
Name 56131 0
Andrew Bivard
Address 56131 0
Hunter Medical Research Institute
1 Kookaburra Cct,
New Lambton Heights, NSW, 2305
Country 56131 0
Australia
Phone 56131 0
+61 02 40420315
Fax 56131 0
Email 56131 0
[email protected]
Contact person for scientific queries
Name 56132 0
Andrew Bivard
Address 56132 0
Hunter Medical Research Institute
1 Kookaburra Cct,
New Lambton Heights, NSW, 2305
Country 56132 0
Australia
Phone 56132 0
+61 02 40420315
Fax 56132 0
Email 56132 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseModafinil In Debilitating fatigue After Stroke (MIDAS): Study protocol for a randomised, double-blinded, placebo-controlled, crossover trial.2016https://dx.doi.org/10.1186/s13063-016-1537-4
EmbaseMIDAS (Modafinil in Debilitating Fatigue after Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.2017https://dx.doi.org/10.1161/STROKEAHA.116.016293
EmbaseShort- 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.2018https://dx.doi.org/10.3389/fneur.2018.00269
EmbasePredicting modafinil-treatment response in poststroke fatigue using brain morphometry and functional connectivity.2019https://dx.doi.org/10.1161/STROKEAHA.118.023813
N.B. These documents automatically identified may not have been verified by the study sponsor.