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Parkinson's DiseasePhase 4NCT00646204

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

A Phase 4 study testing Memantine in people with Parkinson's Disease, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Memantine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Apr 2006to Mar 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PDCMDC 6550 Fannin, Suite 1801

    Houston, Texas, 77030

Other trials in United States

About this 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

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".

Read the detailed description

Patients were enrolled over 11 months from the Parkinson Disease Center and Movement Disorder Clinic at Baylor College of Medicine. PD was diagnosed using standard criteria. Specific inclusion criteria were intentionally broad and included both fluctuating and non-fluctuating patients with a UPDRS "motivation" (#4) score of greater or equal to 2. Patients with dementia (MMSE<24) or taking amantadine were excluded.

The patients signed an informed consent approved by the Baylor College of Medicine Institutional Review Board and the study was registered on Clinical Trials.gov #NCT00646204. The study was funded by a grant from the Forest Research Institute.

After baseline assessments, patients (N=40) were randomized equally to drug (N=20) and placebo (N=20) groups. This was done by a computerized random number generator by a coordinator not otherwise involved in the study.

Patients completed medical and medication histories, a Unified Parkinson's Disease Rating Scale (UPDRS), a battery of neuropsychiatric assessments (see Table 2), global impressions, and adverse events. Patients were not allowed to change other PD medications. The drug/placebo dosing began at 5 mg/day and increased to 5 mg 2x/day, 10 mg / 5 mg, and finally 10 mg 2x/day, in weekly increments. After a safety call (2 weeks after initiation) they returned for identical assessments at week 8. Drug accountability was documented at each visit. An 8-week open label extension was started if desired using the same protocol and assessments.

Tabulations and univariate statistics on difference scores between visits were run using Intercooled Stata V8.0 for windows (Stata Corporation, College Station, Texas 77845), and included Student's t-test with equal variances and contingency table analysis using Pearson's Chi-square test. Statistics were done using LOCF. Corrections for multiple comparisons were not done.

Being tested
Memantine, placebo
Keywords
Parkinson's disease, non-motor symptoms
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MemantineDrug

    Also called Namenda

    10 mg bid

  • placeboDrug

    2 tabs bid

Study groups in NCT00646204
Study groupRoleWhat they receive
1-Active study drugExperimentalmemantine 10 mg bid
Receives: Drug: Memantine
2-placebo comparatorPlacebo comparator2 tabs bid
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 16 weeks

Secondary outcomes (1)

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

    Change from baseline to end of study in the following assessment: global tremor assessment by examiner. The maximum total score is 48 and would indicate a high prevalence of tremor. The minimum total score is 0 and would indicate no tremor.

    Measured: Baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2008 (estimated)
  2. Study startApr 2006
  3. Primary completionFeb 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00646204
Sponsor's protocol ID
H-18912
Status last verified
Nov 2022
First submitted
28 Dec 2007
Last updated
13 Dec 2022
Data monitoring committee
No
Individual data sharing
No: No individual data available

Publications

  • 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.

    PubMed 21193343

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Memantine in people with Parkinson's Disease, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson Disease Rating Scale (UPDRS). (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00646204, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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