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
Scientific
University of Nottingham
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
| Phone | +44 (0)115 840 4792 |
|---|---|
| philip.bath@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STAR |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 18/10/2000 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/10/2000 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom
| Phone | +44 (0)115 840 4791 |
|---|---|
| philip.bath@nottingham.ac.uk | |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
University of Nottingham (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
