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.

niversity College London0 个研究点目标入组 20 人开始时间: 2007年8月15日最近更新: 2019年12月10日

研究概览

暂无简介。

•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

•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)

发起方

niversity College London