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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2006-006949-13-GB |
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Date of registration:
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15/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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. - A dopamine agonist for hemispatial neglect and motor deficits following stroke.
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Scientific title:
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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. - A dopamine agonist for hemispatial neglect and motor deficits following stroke. |
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Date of first enrolment:
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16/10/2007 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006949-13 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Randomization test design (originally developed by Fisher)
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Confirmed clinical diagnosis of right-hemisphere stroke.
2. Able to give informed consent.
3. Presence of left hemispatial neglect defined by a deficit in finding leftward targets on standard cancellation or visual search tests. (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 capacity).
4. 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 5. Age over 18 years.
6. 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).
7. Able and willing to use patches of drug/placebo and assessments at regular intervals as defined by the protocol.
8. Able to comply with study requirements.
9. If female and of child-bearing potential, subject has a negative serum pregnancy test within two days of enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Pre-existing neurological conditions that would confound cognitive and motor assessments, e.g. dementia, Parkinson’s disease, Multiple Sclerosis.
2. 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.
3. Systolic blood pressure less than 120 mmHg and / or diastolic less than 70 mmHg.
4. Exposure to any other investigational drug within 30 days of enrollment in the study.
5. History (obtained from patient and medical records) of clinically significant drug or alcohol abuse within 6 months prior to enrolment into the study.
6. Pregnancy (because the effects of rotigotine on the foetus 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 enrolment.
7. Mothers who are breast feeding (because the effects of rotigotine on the newborn have not been established)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Hemispatial neglect and motor deficits following right-hemisphere stroke.
MedDRA version: 9.1
Level: LLT
Classification code 10042244
Term: Stroke
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Intervention(s)
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Trade Name: Neupro
Product Name: Rotigotine
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use
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Primary Outcome(s)
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Primary end point(s): Completion of study protocol which lasts 5 weeks and 3 days for every participant.
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Secondary Objective: If rotigotine reduces hemispatial neglect, does it do so by improving memory for spatial locations, improving the ability to sustain attention or ignore distracting information, or a combination of these processes?
If motor deficits are improved by rotigotine, does the drug exert its beneficial effects by improving dexterity of the limbs?
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Main Objective: To assess the effects of the drug rotigotine on the syndrome of hemispatial neglect and motor deficits following right-hemisphere stroke.
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Secondary ID(s)
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BRD/06/162
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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