Working… Menu
Trial record 6 of 14 for:    glutamate antagonist | Parkinson Disease

Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646204
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : May 1, 2009
Forest Laboratories
Information provided by:
Baylor College of Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: Memantine Drug: placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. This is an exploratory study. The primary efficacy point will be global impressions. [ Time Frame: baseline versus study end ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must be between the ages of 18 and 80 inclusive.
  2. Each subject must meet standard criteria for PD.
  3. 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.
  4. Subjects must be in generally good health as evidenced by previous medical history and clinical examination.
  5. 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.
  6. 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.
  7. 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.
  8. Subjects must be accessible by telephone.
  9. 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.
  10. 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:

  1. Subjects who do not meet inclusion criteria.
  2. Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
  3. Subjects who can not maintain an identical dose of any medicine that may affect PD symptoms or signs during their entire study involvement.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646204

Layout table for location information
United States, Texas
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Forest Laboratories
Layout table for investigator information
Principal Investigator: William G Ondo, MD Baylor College of Medicine
Layout table for additonal information
Responsible Party: William G. Ondo, MD, Baylor College of Medicine Identifier: NCT00646204    
Other Study ID Numbers: H-18912
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009
Keywords provided by Baylor College of Medicine:
Parkinson's disease
non-motor symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Excitatory Amino Acid Antagonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Agents