To assess the safety and feasibility of administering Dexamphetamine after stroke and its effect on cerebral and cardiac haemodynamics

ISRCTN ISRCTN36285333
DOI https://doi.org/10.1186/ISRCTN36285333
Secondary identifying numbers N/A
Submission date
26/08/2005
Registration date
28/10/2005
Last edited
17/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Philip Bath
Scientific

University of Nottingham
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Phone +44 (0)115 840 4792
Email philip.bath@nottingham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSTAR
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedIschaemic Stroke
InterventionEligible 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dexamphetamine
Primary outcome measureThe safety, tolerabilty and feasibility of dexamphetamine in acute ischaemic stroke and its effect on motor impairment, cerebral and cardiac haemodynamics.
Secondary outcome measuresAt 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 study start date18/10/2000
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants42
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/10/2000
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Nottingham
Nottingham
NG5 1PB
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom

Phone +44 (0)115 840 4791
Email philip.bath@nottingham.ac.uk
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

University/education

University of Nottingham (UK)
Private sector organisation / Universities (academic only)
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2007 Yes No