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| Sponsors and Collaborators: |
Baylor College of Medicine Forest Laboratories |
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00646204 |
Purpose
To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's disease.
Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasized. Problematic symptoms include varying degrees of dementia, psychosis, diminished assertiveness and confidence, general fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder, and a common yet difficult to define sense of "not feeling well".
| Condition | Intervention | Phase |
|
Parkinson's Disease |
Drug: Memantine Drug: placebo |
Phase IV |
| Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
| MedlinePlus related topics: | Parkinson's Disease Tremor |
| ChemIDplus related topics: | Memantine Memantine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASE |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
memantine 10 mg bid
|
Drug: Memantine
10 mg bid
|
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2: Placebo Comparator
2 tabs bid
|
Drug: placebo
2 tabs bid
|
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
6. Subjects currently taking Amantadine. 7. Subjects with greater than moderate dementia (MMSE<24). 8. Subjects with co-morbid disease that in the investigators decision could interfere with treatment with memantine.
Contacts and Locations| Contact: Lina Shinawi, CCRC | 713-798-5519 | lshinawi@bcm.edu |
| United States, Texas | |||||
| PDCMDC 6550 Fannin, Suite 1801 | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Principal Investigator: William G Ondo, MD | |||||
| Sub-Investigator: Joseph Jankovic, MD | |||||
| Sub-Investigator: Joohi Jimenez-Shahed, MD | |||||
| Baylor College of Medicine |
| Forest Laboratories |
| Principal Investigator: | William G Ondo, MD | Baylor College of Medicine |
More Information
| Responsible Party: | Baylor College of Medicine ( William G. Ondo, MD ) |
| Study ID Numbers: | H-18912 |
| First Received: | December 28, 2007 |
| Last Updated: | March 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00646204 |
| Health Authority: | United States: Institutional Review Board |
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