NCT00663338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 21, 2011

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

April 21, 2008

Last Update Submit

February 18, 2011

Conditions

Right Hemisphere StrokeHemispatial NeglectMotor Deficit

Keywords

StrokeHemispatial neglectUnilateral neglectSpatial neglectMotorWeakness

Outcome Measures

Primary Outcomes (2)

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

    38 days

  • Tests of motor control.

    38 days

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Rotigotine

Interventions

RotigotineDRUG

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

Also known as: Neupro
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed clinical diagnosis of right-hemisphere stroke.
  • Able to give informed consent.
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Homerton University Hospital

London, E9 6SR, United Kingdom

Location

Charing Cross Hospital

London, W68RF, United Kingdom

Location

The National Hospital for Neurology & Neurosurgery

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Perceptual DisordersNeurologic ManifestationsStrokeAsthenia

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 22, 2008

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

February 21, 2011

Record last verified: 2010-01

Locations

GB(3)