Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke
This study has been completed.
Sponsor:
University College, London
Collaborator:
Medical Research Council
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT00663338
First received: April 21, 2008
Last updated: February 18, 2011
Last verified: January 2010
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 21, 2008 |
| Last Updated Date | February 18, 2011 |
| Start Date ICMJE | January 2010 |
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
|
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00663338 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke |
| Official Title ICMJE | 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 |
| 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. |
| 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. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Rotigotine
Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.
Other Name: Neupro |
| Study Arm (s) | Experimental: A
All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.
Intervention: Drug: Rotigotine |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 20 |
| Completion Date | July 2010 |
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United Kingdom |
| Administrative Information | |
| NCT Number ICMJE | NCT00663338 |
| Other Study ID Numbers ICMJE | BRD/06/162, MRC77096 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Dr Nick McNally, UCLH/UCL Biomedical Research Unit |
| Study Sponsor ICMJE | University College, London |
| Collaborators ICMJE | Medical Research Council |
| Investigators ICMJE | Not Provided |
| Information Provided By | University College, London |
| Verification Date | January 2010 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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