Condition category
Circulatory System
Date applied
30/03/2007
Date assigned
30/03/2007
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sunnybrook.ca/

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

Publication citations

Additional files

Editorial Notes