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Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663338

Locations
United Kingdom
Charing Cross Hospital
London, United Kingdom, W68RF
Homerton University Hospital
London, United Kingdom, E9 6SR
The National Hospital for Neurology & Neurosurgery
London, United Kingdom, WC1N 3BG
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:
Cerebral Infarction
Perceptual Disorders
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
N 0437
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014