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| [ ...Back to search results ] | [ Print-friendly version ] |
| To assess the safety and feasibility of administering Dexamphetamine after stroke and its effect on cerebral and cardiac haemodynamics |
| ISRCTN | ISRCTN36285333 |
| ClinicalTrials.gov identifier | |
| Public title | To assess the safety and feasibility of administering Dexamphetamine after stroke and its effect on cerebral and cardiac haemodynamics |
| Scientific title | |
| Acronym | STAR |
| Serial number at source | N/A |
| 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 |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ischaemic Stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 18/10/2000 |
| Anticipated end date | 31/03/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 42 |
| Interventions | 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. |
| Primary outcome measure(s) | The safety, tolerabilty and feasibility of dexamphetamine in acute ischaemic stroke and its effect on motor impairment, cerebral and cardiac haemodynamics. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | University of Nottingham (UK) |
| Trial website | |
| Publications | 2007 results in http://www.ncbi.nlm.nih.gov/17443208 |
| Contact name | Prof Philip Bath |
| Address |
University of Nottingham
Clinical Sciences Building City Hospital Campus Hucknall Road |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Tel | +44 (0)115 840 4792 |
| Fax | +44 (0)115 840 4790 |
| philip.bath@nottingham.ac.uk | |
| Sponsor | University of Nottingham (UK) |
| Address |
Clinical Sciences Building
City Hospital Campus Hucknall Road |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Tel | +44 (0)115 840 4791 |
| Fax | +44 (0)115 840 4790 |
| philip.bath@nottingham.ac.uk | |
| Date applied | 26/08/2005 |
| Last edited | 17/09/2009 |
| Date ISRCTN assigned | 28/10/2005 |
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