Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

NCT ID: NCT00663338

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-07-31

Brief Summary

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.

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.

Conditions

Right Hemisphere Stroke; Hemispatial Neglect; Motor Deficit

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.

Interventions

Rotigotine

Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.

Intervention Type: DRUG

Other Intervention Names

Neupro

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

UCLH/UCL Biomedical Research Unit

Locations

Homerton University Hospital

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

The National Hospital for Neurology & Neurosurgery

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

MRC77096

Identifier Type: -

Identifier Source: secondary_id

BRD/06/162

Identifier Type: -

Identifier Source: org_study_id