Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

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

Sponsors

Lead Sponsor: University College, London

Collaborator: Medical Research Council

Source University College, London
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.

Overall Status Completed
Start Date January 2010
Completion Date July 2010
Primary Completion Date June 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention). 38 days
Tests of motor control. 38 days
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rotigotine

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

Arm Group Label: A

Other Name: 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

- 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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Homerton University Hospital | London, E9 6SR, United Kingdom
Charing Cross Hospital | London, W68RF, United Kingdom
The National Hospital for Neurology & Neurosurgery | London, WC1N 3BG, United Kingdom
Location Countries

United Kingdom

Verification Date

January 2010

Responsible Party

Name Title: Dr Nick McNally

Organization: UCLH/UCL Biomedical Research Unit

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: A

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov