Contact information
Type
Scientific
Primary contact
Dr Sandra Elizabeth Black
ORCID ID
Contact details
Sunnybrook Health Sciences Centre
Cognitive Neurology
Room A421
2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada
+1 416 480 4551
sandra.black@sunnybrook.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-38134
Study information
Scientific title
Acronym
Study hypothesis
Hypothesis:
Clinical recovery, assessed by validated scales of neurologic impairment and disability at standardised times, will be significantly enhanced in patients recovering from hemiparetic stroke, receiving Amphetamine (AMPH) coupled with rehabilitation versus placebo coupled with rehabilitation.
Objective:
This project aims to determine whether AMPH paired with rehabilitative training can promote adaptive neuroplasticity and improve clinically-meaningful outcomes in patients recovering from hemiparetic stroke.
Ethics approval
Approval received from the Research Ethics Board of Sunnybrook & Women's College Health Science Centre (Canada) on the 9th November 1999 (ref: 214-1999).
Study design
Multicentre, two-arm, randomised parallel group placebo trial with participant, investigator, caregiver, outcome assessor, and data analyst blinding.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Stroke
Intervention
10 mg amphetamine followed 90 minutes later by one hour physiotherapies, starting five to ten days post stroke, every three to four days for ten drug therapy sessions, versus a matched placebo.
Please note that this trial is now completed.
Contact for public queries:
Dr. David Gladstone
Sunnybrook Health Sciences Centre (Canada)
A442-2075 Bayview Avenue
Toronto, ON
M4N 3M5
Canada
Tel: +1 416 480 4866
Fax: +1 416 480 5753
Email: david.gladstone@sunnybrook.ca
Intervention type
Drug
Phase
Not Applicable
Drug names
Amphetamine
Primary outcome measures
Recovery of hemiparesis measured by the Fugl Meyer Motor Assessment at 13 time points up to three months.
Secondary outcome measures
All secondary outcomes are measured at baseline, six weeks, and at three months:
1. National Institute of Health Stroke Scale (NIHSS)
2. Western Aphasia Battery (WAB)
3. Sunnybrook Neglect Assessment Procedure (SNAP)
4. Montgomery/Ashberg Depression Rating Scale
5. Apathy Scale
6. Structured Clinical Interview for Diagnostic and Statistical Manual of mental disorders fourth edition (SCID-DSM-IV)
7. Ideomotor Praxis
8. Chedoke-McMaster Stroke Assessment
9. Clinical Outcomes Variable Scale (COVS)
10. Stroke Rehabilitation Assessment of Movement (STREAM)
11. Barthel Index Scale
12. Functional Independence Measure (FIM)
13. Modified Rankin Scale (MRS)
14. Stroke Impact Scale (SIS)
15. Chedoke Arm and Hand Activity Inventory
16. Mini Mental State Examination (MMSE)
Overall trial start date
01/02/2000
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female or male, 30 to 65 year old
2. Ischaemic hemispheric stroke patients with moderate to severe hemiparesis
3. Medically able to participate in a rehabilitation program and expected to survive three months post-stroke
4. Pre-morbid modified Rankin score zero or one
5. Informed consent from patient or substitute decision maker
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
71
Participant exclusion criteria
1. Brainstem or cerebellar stroke
2. Primary intracerebral haemorrhage
3. Pre-existing neurologic deficit (e.g. from prior stroke) that could interfere with assessments
4. Pregnancy and lactation
5. Prior history of dementia
6. Known hypersensitivity to sympathomimetic amines
7. Unstable cardiac arrhythmia or hypertension not controlled by medication (greater than 170/105 mmHg)
18. History of psychosis or tic disorder
19. Untreated hyperthyroidism
20. Concomitant use of alpha-adrenergic antagonists or agonists
21. Concomitant use of monoamine oxidase inhibitors or use within the preceding 14 days
Recruitment start date
01/02/2000
Recruitment end date
31/12/2002
Locations
Countries of recruitment
Canada
Trial participating centre
Sunnybrook Health Sciences Centre
Ontario
M4N 3M5
Canada
Sponsor information
Organisation
Sunnybrook Health Sciences Centre (Canada)
Sponsor details
Research Administration
S123- 2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada
+1 416 480 6100 ext 5721
judy.tong@sunnybrook.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-38134)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary