Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dagmar Long

ORCID ID

Contact details

Care of the Elderly
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes