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

• ClinicalTrials.gov Identifier: NCT00646204
• Recruitment Status: Completed
• First Posted: March 28, 2008
• Last Update Posted: May 1, 2009
• Sponsor: Baylor College of Medicine
• Collaborator: Forest Laboratories
• Information provided by: Baylor College of Medicine

Study Description

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

Study Design

• 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
• 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
• Study Start Date: April 2006
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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

• Responsible Party: William G. Ondo, MD, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00646204 History of Changes
• Other Study ID Numbers: H-18912
• First Posted: March 28, 2008
• 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:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Excitatory Amino Acid Antagonists; Memantine; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Excitatory Amino Acid Agents