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

NCT00646204 | Completed Phase 4 Results

• 1 other identifier: H-18912
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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".

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; non-motor symptoms

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson Disease Rating Scale (UPDRS).

  Assess the overall change from baseline in ON state motor United Parkinson Disease Rating scale (UPDRS) scores as assessed in the scale. The minimum score is 0 and the maximum score 199. The maximum score of 199 means the worst possible disability from Parkinson's Disease.

  Baseline and 16 weeks

Secondary Outcomes (1)

• Analyses Will be Computed for the Categorical Dependent Variable (DV): Global Tremor Assessment by Examiner

  Baseline and 16 weeks

Study Arms (2)

1-Active study drug

EXPERIMENTAL

memantine 10 mg bid

Drug: Memantine

2-placebo comparator

PLACEBO COMPARATOR

2 tabs bid

Drug: placebo

Interventions

Memantine DRUG

10 mg bid

Also known as: Namenda

1-Active study drug

placebo DRUG

2 tabs bid

2-placebo comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Forest Laboratories: collaborator

Study Sites (1)

PDCMDC 6550 Fannin, Suite 1801

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ondo WG, Shinawi L, Davidson A, Lai D. Memantine for non-motor features of Parkinson's disease: a double-blind placebo controlled exploratory pilot trial. Parkinsonism Relat Disord. 2011 Mar;17(3):156-9. doi: 10.1016/j.parkreldis.2010.12.003. Epub 2010 Dec 30.

  PMID: 21193343 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: William G. Ondo, MD
• Organization: Baylor College of Medicine/Houston Methodist

wondo@houstonmethodist.org

713-363-8930

Study Officials

• William G Ondo, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: March 28, 2008
• Study Start: April 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 13, 2022
• Results First Posted: December 13, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)