CClinicalTrials.gg
CompletedNCT00663338Updated Feb 21, 2011

Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

A Phase 2 interventional study of Rotigotine in Right Hemisphere Stroke, Hemispatial Neglect and Motor Deficit, sponsored by University College, London. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-21.

Sponsored by University College, London · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Right Hemisphere Stroke
  • Hemispatial Neglect
  • Motor Deficit

Keywords

  • Stroke
  • Hemispatial neglect
  • Unilateral neglect
  • Spatial neglect
  • Motor
  • Weakness
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    A

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

    Drug: Rotigotine

Interventions

  • DrugRotigotine

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

    Also known as: Neupro

06

What researchers measure

Primary outcomes

  1. Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).

    Time frame: 38 days

  2. Tests of motor control.

    Time frame: 38 days

07

Study locations

3 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00663338
Lead sponsor
University College, London
Collaborators
Medical Research Council
First posted
Apr 22, 2008
Start date
Jan 2010
Primary completion
Jun 2010
Completion
Jul 2010
Last update
Feb 21, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion