A Pilot Clinical Trial Of Memantine for Essential Tremor

Completed · Phase 4

Conditions studied: Essential Tremor

In brief

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.

Key facts

Study ID

NCT00439699

Run by

VA Greater Los Angeles Healthcare System

People needed

16

Starts

2007-02-01

Expected to finish

2009-12-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.
• Tremor potentially due to head trauma, hyperthyroidism, cerebrovascular disease, multiple sclerosis, polyneuropathy, or family history of Fragile X syndrome.
• Known renal disease with creatinine level outside normal range.

Where it is running

• VA Greater Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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