A Pilot Clinical Trial Of Memantine for Essential Tremor

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Greater Los Angeles Healthcare System
• Collaborators: Forest Laboratories; Ralph M. Parsons Foundation
• Treatments: Memantine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.