Status:
COMPLETED
A Pilot Clinical Trial Of Memantine for Essential Tremor
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Collaborating Sponsors:
Ralph M. Parsons Foundation
Forest Laboratories
Conditions:
Essential Tremor
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Detailed Description
Background: Essential tremor (ET) is the most common movement disorder but has relatively few effective and tolerated therapies. Tremor in ET is believed to be generated by a central oscillator, the i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00439699
Start Date
February 1 2007
End Date
December 1 2009
Last Update
June 22 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Greater Los Angeles
Los Angeles, California, United States, 90073