Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke
This study has been completed.
Sponsor:
University College, London
Collaborator:
Medical Research Council
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT00663338
First received: April 21, 2008
Last updated: February 18, 2011
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Right Hemisphere Stroke Hemispatial Neglect Motor Deficit |
Drug: Rotigotine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University College, London:
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: | 20 |
| Study Start Date: | January 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.
|
Drug: Rotigotine
Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.
Other Name: Neupro
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663338
Locations
| United Kingdom | |
| 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 | |
Sponsors and Collaborators
University College, London
Medical Research Council
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Nick McNally, UCLH/UCL Biomedical Research Unit |
| ClinicalTrials.gov Identifier: | NCT00663338 History of Changes |
| Other Study ID Numbers: | BRD/06/162, MRC77096 |
| Study First Received: | April 21, 2008 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United Kingdom: Department of Health |
Keywords provided by University College, London:
|
Stroke Hemispatial neglect Unilateral neglect |
Spatial neglect Motor Weakness |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Perceptual Disorders Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Dopamine |
N 0437 Dopamine Agonists Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013