A Pilot Clinical Trial Of Memantine for Essential Tremor

NCT00439699 | Completed Phase 4

• 1 other identifier: 0033
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain information on whether or not the medication Memantine reduces tremor in persons with essential tremor and is well-tolerated.

Conditions

Essential Tremor

Keywords

Essential Tremor; Memantine; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• The degree of tremor at the end of the dose adjustment phase compared to baseline

  Six months

Secondary Outcomes (2)

• Quality of Life.

  Six months

• Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.

  Six months

Study Arms (1)

Memantine

EXPERIMENTAL

Tremor reduction

Drug: Memantine

Interventions

Memantine DRUG

Mematine administration

Memantine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Subject diagnosed with essential tremor affecting both upper extremities.
• Subject has been diagnosed for at least one year with tremor that is troublesome, so that improvement of tremor would improve the quality of life.
• Subject has tremor with a tremor rating scale severity of 2 to 4 in one or both upper extremities in the tremor rating scale during posture and/or kinesis.
• Subject has not had satisfactory tremor response to at least one anti-tremor medication.
• Subject is able to comply with all testing and follow-up visit requirements.
• Subject is able to abstain from alcohol for at least 12 hours prior to each Study Visit and from caffeinated beverages on the day of the Visit.
• Subject has voluntarily signed an informed consent in accordance with institutional policies.
• Subject is either
• Not taking medication for Essential Tremor and has not done so for at least 28 days prior to Visit 1.
• Taking medication for Essential Tremor and has been taking a stable dose so for at least 28 days prior to Visit 1.

You may not qualify if:

• Subject has progressive neurological disease other than Essential Tremor.
• Subject has history of alcoholism or drug abuse within the past year.
• Subject has history of mania, bipolar depressive disorder, schizophrenia, or other major psychiatric disorder.
• Subject drinks more than 2 glasses of wine or equivalent per day in last 30 days.
• Subject has received botulinum injection of the upper extremities in the past 6 months.
• Subject is currently using investigational device.
• Subject has taken an investigational drug within a clearance duration of 5 times the half-life of the investigational drug.
• Subject is pregnant or a female of childbearing potential not using adequate contraception.
• Subject has a medical condition likely to result in hospitalization.
• Known allergy to memantine or amantadine.
• Taking medication that alkalinizes the urine, such as carbonic anhydrase inhibitor or sodium bicarbonate.
• Any disorder or condition that may interfere with the absorption, the distribution, or excretion of drugs.
• Taking medication known to cause postural tremor, that in the clinical judgement of the investigator is contributing to the subject's tremor.
• Receiving deep brain stimulation within two weeks prior to Visit 1 or has potential need for deep brain stimulation during the study.
• Has received ablative thalamotomy or gamma knife thalamotomy within six months of study onset.

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead
• Ralph M. Parsons Foundation: collaborator
• Forest Laboratories: collaborator

Study Sites (1)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Memantine

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Adrian Handforth, M.D.

  Veteran Affairs Greater Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief, Neurology, VAMC

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)