Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease
This study has been completed.
Sponsor:
Baylor College of Medicine
Collaborator:
Forest Laboratories
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00646204
First received: December 28, 2007
Last updated: April 30, 2009
Last verified: April 2009
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Baylor College of Medicine:
Primary Outcome Measures:
- This is an exploratory study. The primary efficacy point will be global impressions. [ Time Frame: baseline versus study end ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Analyses will be computed for the categorical dependent variables (DV): spirograph, pouring, subjective ADL, observed tremor, global assessment by examiner, global assessment by patient, and subjective assessment by patient scores. [ Time Frame: baseline versus end of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
memantine 10 mg bid
|
Drug: Memantine
10 mg bid
Other Name: Namenda
|
|
Placebo Comparator: 2
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 |
Criteria
Inclusion Criteria:
- Subjects must be between the ages of 18 and 80 inclusive.
- Each subject must meet standard criteria for PD.
- All patients on dopaminergic therapy must report benefit. -No other abnormal neurological signs. -No direct or indirect trauma to the nervous system within 3 months preceding the onset of PD. -No convincing evidence of sudden onset or evidence of stepwise deterioration.
- Subjects must be in generally good health as evidenced by previous medical history and clinical examination.
- Subjects will be allowed to take any PD medication with the exception of amantadine. They will also be allowed to take medications approved for the use of Alzheimer's disease.
- Subjects will be required to be on a stable dose of all medications for at least two weeks prior to entry into the study and may not alter these medications throughout the study.
- If subjects are on an anti-depressant medications, a stable dose of these will be required for at least six weeks prior to entry into the study.
- Subjects must be accessible by telephone.
- If the subject is a female of childbearing age, she must have had: a hysterectomy, or tubal ligation, or otherwise be incapable or pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.
- Female of childbearing age must have had a negative urine pregnancy test within one week of study entry. 11. Prior to participation in this study, each subject must sign an informed consent.
Exclusion Criteria:
- Subjects who do not meet inclusion criteria.
- Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
- Subjects who can not maintain an identical dose of any medicine that may affect PD symptoms or signs during their entire study involvement.
- Subjects who have exhibited meaningful psychiatric disease not thought to be related to PD. (Depression and psychosis typical for PD will not be excluded). 5. Subjects who have previously taken memantine.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646204
Locations
| United States, Texas | |
| PDCMDC 6550 Fannin, Suite 1801 | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Baylor College of Medicine
Forest Laboratories
Investigators
| Principal Investigator: | William G Ondo, MD | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | William G. Ondo, MD, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00646204 History of Changes |
| Other Study ID Numbers: | H-18912 |
| Study First Received: | December 28, 2007 |
| Last Updated: | April 30, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baylor College of Medicine:
|
Parkinson's disease non-motor symptoms |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013