Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050119120
Study information
Scientific title
Acronym
Study hypothesis
Dexamphetamine has repeatedly been shown to enhance recovery after experimental brain injury in animal models. Our aim is to see whether dexamphetamine, given with rehabilitation treatment early after a stroke, is able to improve the recovery of limb weakness and, if so, to see which groups of patients respond best.
Ethics approval
Not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Stroke
Intervention
This is a placebo-controlled, double-blind, randomised pilot study based within two rehabilitation stroke units. Eligible patients will be randomised to receive either dexamphetamine or placebo, with two-thirds of the subjects receiving dexamphetamine.
The medication will be given as a capsule by mouth about 1 h before a 60 min session of rehabilitation. The rehabilitation treatment will be provided in the standard way except that rehabilitation sessions will be timed to occur during the period of peak effect of the study medication.
Measurements of recovery will assess residual weakness and disability and will be made by the same health-trained research assistant at 3 and 6 weeks after recruitment and at 3 months after the stroke.
Added 27/07/09: trial was stopped due to lack of funding.
Intervention type
Drug
Phase
Not Specified
Drug names
dexamphetamine
Primary outcome measures
The extent to which a subject's weakness has recovered at 3 months after the stroke. Interim assessments will occur at 3 and 6 weeks after beginning the trial medication. Assessment of recovery will document residual weakness of the affected arm, trunk and leg (using the Rivermead motor assessment scale) and the subject's degree of independence in basic activities of daily living (using the Barthel Index). In parallel, the subjects mood state will be assessed for depression and lack of motivation.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/10/2002
Overall trial end date
16/10/2004
Reason abandoned
Lack of funding
Eligibility
Participant inclusion criteria
All patients aged 18 years and over newly admitted to the stroke units in Bradford and Leeds will be assessed by a research assistant for potential recruitment.
Eligible subjects will
1. have had a new stroke resulting in a right or left-sided weakness of sufficient severity to require an anticipated minimum 4-week stay on the stroke unit.
2, have a Computed Tomography (CT) scan to exclude intracranial haemorrhage
3. be medically stable and able to participate in daily rehabilitation.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. unable to understand language as a result of stroke
2. any memory impairment (pre-existing or as a consequence of the stroke)
3. stable heart disease and untreated high blood pressure
4. any psychiatric treatment within the past 5 years or a past history of drug or alcohol dependence.
Recruitment start date
16/10/2002
Recruitment end date
16/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Care of the Elderly
Bradford
BD5 0NA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Bradford Hospitals NHS Trust (UK)
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