Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

Hemispatial Neglect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663338
• Other study ID #: BRD/06/162
• Secondary ID: MRC77096
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2008
• Last updated: February 18, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: January 2010
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemispatial Neglect
• Motor Deficit
• Perceptual Disorders
• Right Hemisphere Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London
United Kingdom	Homerton University Hospital	London
United Kingdom	The National Hospital for Neurology & Neurosurgery	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).		38 days	No
Primary	Tests of motor control.		38 days	No