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Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663338
First Posted: April 22, 2008
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Research Council
Information provided by:
University College, London
  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: Intervention Model: Single Group Assignment
Masking: Double (Participant, 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 ]
  • Tests of motor control. [ Time Frame: 38 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663338


Locations
United Kingdom
Homerton University Hospital
London, United Kingdom, E9 6SR
Charing Cross Hospital
London, United Kingdom, W68RF
The National Hospital for Neurology & Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Medical Research Council
  More Information

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
First Submitted: April 21, 2008
First Posted: April 22, 2008
Last Update Posted: February 21, 2011
Last Verified: January 2010

Keywords provided by University College, London:
Stroke
Hemispatial neglect
Unilateral neglect
Spatial neglect
Motor
Weakness

Additional relevant MeSH terms:
Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Dopamine
Rotigotine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Dopamine Agonists