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 measure
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 (if study stopped)
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
Universities (academic only)
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/17443208