Condition category
Circulatory System
Date applied
26/08/2005
Date assigned
28/10/2005
Last edited
17/09/2009
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

Prof Philip Bath

ORCID ID

Contact details

University of Nottingham
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4792
philip.bath@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

STAR

Study hypothesis

1. To study the safety and feasibility of administering dexamphetamine twice weekly in 42 patients with a recent ischaemic stroke, and its effect on motor impairment
2. To study the effect of dexamphetamine on cerebral and cardiac haemodynamics in stroke patients

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ischaemic Stroke

Intervention

Eligible patients who have provided consent will be randomly assigned to receive either dexamphetamine or placebo control. Dexamphetamine or placebo control will be administered orally twice a week with alternating 3 or 4 day separations. There will be a total of 10 doses covering a treatment period of 31 days. Further measurements of haemodynamics will be made 90 minutes after the first dose and immediately before, and 90 minutes after, the second dose. Measurements of the Barthel, Rankin and Scandinavian Neurological Stroke Scale (SNSS) will also be repeated 90 minutes after the second dose. Patients will remain as inpatients for the 7 days required. Xenon CT will be performed on selected patients (approx 8) to assess the dexamphetamine effect on cerebral perfusion before and 1 hour after the first administration.

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamphetamine

Primary outcome measures

The safety, tolerabilty and feasibility of dexamphetamine in acute ischaemic stroke and its effect on motor impairment, cerebral and cardiac haemodynamics.

Secondary outcome measures

At outcome (35 days) and follow up (90 days): Modified Rankin, Barthel Index, SNSS, Motricity Index, Grip Strength, Thumb-finding test, Sheffield aphasia screening, modified Mini-Mental State Examination (MMSE), Zung depression, EuroQUOL, 10-Hole Peg Test.

Overall trial start date

18/10/2000

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical stroke 3-30 days post ictus
2. Ischaemic stroke on computed tomography (CT)/magnetic resonance imaging (MRI)
3. Motor weakness (Motricity Index arm 0-99 inclusive)
4. Patients expected to stay in hospital for a further 8 days

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Pre-morbid Barthel Index <12/20
2. Dementia
3. No enteral access in prescence of dysphagia
4. Moderate-severe hypertension (systolic blood pressure [BP] >160 or diastolic BP >100)
5. Clinical ischaemic heart disease, previous or current angina, myocardial infarction
6. Hyperexcitability or agitated states
7. Current hyperthyroidism
8. History of alcohol or drug abuse
9. Glaucoma
10. Predisposition to tics or Tourette Syndrome
11. Epilepsy or recent convulsions
12. Liver dysfunction (aspartate aminotransferase [AST] 3 x normal)
13. Renal dysfunction (creatinine >130)
14. Pregnancy and breastfeeding
15. Recent monoamine oxidase inhibitor (MAOI) usage
16. Porphyria

Recruitment start date

18/10/2000

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4791
philip.bath@nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

2007 results in http://www.ncbi.nlm.nih.gov/17443208

Publication citations

Additional files

Editorial Notes