Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke
This study has been completed.
Medical Research Council
Information provided by:
University College, London
First received: April 21, 2008
Last updated: February 18, 2011
Last verified: January 2010
The aim of this study is to assess the effect of the drug rotigotine on the syndrome of hemispatial neglect and motor deficits following strokes affecting the right hemisphere of the brain.
Right Hemisphere Stroke
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Multi-centre Exploratory Study to Evaluate the Efficacy of the Dopamine Receptor Agonist Rotigotine in the Treatment of Hemispatial Neglect and Motor Deficits Following Stroke
Primary Outcome Measures:
- Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention). [ Time Frame: 38 days ] [ Designated as safety issue: No ]
- Tests of motor control. [ Time Frame: 38 days ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.
Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.
Other Name: Neupro
Hemispatial neglect and motor deficits remain major problems following right-hemisphere stroke. This study aims to assess the effect of rotigotine on hemispatial neglect, its component cognitive deficits (including spatial working memory and sustained attention) and motor deficits following right-hemisphere stroke.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Confirmed clinical diagnosis of right-hemisphere stroke.
- Able to give informed consent.
- Presence of left hemispatial neglect defined by a deficit in finding leftward targets on standard cancellation or visual search tests68-70. (A deficit on the line bisection test alone will not be sufficient for inclusion, as a previous study shows that there is no significant relationship between performance on this test and spatial working memory capacity37).
- Presence of motor deficits: all patients will have suffered from first-ever clinically defined stroke resulting in weakness of at least wrist and finger extensors, and hand interossei (to </= 4+ on the Medical Research Council scale), at the time of recruitment.
- Age over 18 years.
- More than 9 days since stroke-onset (Note that on our protocol patches do not commence until a minimum of 6 days after the study begins. Thus patients will not receive drug / placebo until a minimum of 15 days post-stroke).
- Able and willing to use patches of drug/placebo and assessments at regular intervals as defined by the protocol.
- Able to comply with study requirements.
- If female and of child-bearing potential, subject has a negative serum pregnancy test within two days of enrollment.
- Pre-existing neurological conditions that would confound cognitive and motor assessments, e.g. dementia, Parkinson's disease, Multiple Sclerosis.
- Presence of acute concomitant illness, e.g. infection, unstable angina, myocardial infarction or heart, respiratory, renal or liver failure which, based on clinical judgment, would be considered to confound interpretation of results.
- Systolic blood pressure less than 120 mmHg and / or diastolic less than 70 mmHg.
- Exposure to any other investigational drug within 30 days of enrollment in the study.
- History (obtained from patient and medical records) of clinically significant drug or alcohol abuse within 6 months prior to enrollment into the study.
- Pregnancy (because the effects of rotigotine on the fetus and mother in pregnancy are not known). If female and of child-bearing potential, a serum pregnancy test will be performed within two days of enrollment.
- Mothers who are breast feeding (because the effects of rotigotine on the newborn have not been established)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663338
|The National Hospital for Neurology & Neurosurgery
|London, United Kingdom, WC1N 3BG |
|Charing Cross Hospital
|London, United Kingdom, W68RF |
|Homerton University Hospital
|London, United Kingdom, E9 6SR |
University College, London
Medical Research Council
No publications provided
||Dr Nick McNally, UCLH/UCL Biomedical Research Unit
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 21, 2008
||February 18, 2011
||United Kingdom: Department of Health
Keywords provided by University College, London:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action