Back to resultsA Pilot Clinical Trial Of Memantine for Essential Tremor
Primary Purpose
Essential Tremor
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Memantine
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Essential Tremor, Memantine, Clinical Trial
Eligibility 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.
Sites / Locations
- VA Greater Los Angeles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Memantine
Arm Description
Tremor reduction
Outcomes
Primary Outcome Measures
The degree of tremor at the end of the dose adjustment phase compared to baseline
Secondary Outcome Measures
Quality of Life.
Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Full Information
NCT ID
NCT00439699
First Posted
February 22, 2007
Last Updated
June 20, 2012
Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
Ralph M. Parsons Foundation, Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00439699
Brief Title
A Pilot Clinical Trial Of Memantine for Essential Tremor
Official Title
A Pilot Clinical Trial of Memantine for Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
Ralph M. Parsons Foundation, Forest Laboratories
4. Oversight
5. Study Description
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 inferior olivary nucleus. Membrane potentials in neurons of this nucleus oscillate at tremor frequency. Evidence indicates that the ability of this nucleus to produce tremor is medicated by glutamate acting on the NMDA receptor. As NMDA receptor antagonists suppress tremor, it is suggested that memantine, a low affinity NMDA antagonist, will be effective for essential tremor.
Objective: To assess the efficacy, safety and stability of response to memantine in a pilot single-site feasibility rising-dose trial in the treatment of essential tremor.
Method: Subjects with bilateral upper extremity essential tremor, on no essential tremor therapy, or on a stable-dose therapy, will have laboratory tests and EKG tests at a screening visit. Eligible subjects will have baseline tremor assessments with standardized rating scales. The tremor will be videotaped. In the first titration step, all subjects will take memantine at the dose of 5 mg/day for 2 weeks, then 5 mg twice a day for another 2 weeks, and tremor again assessed. In the second titration step the dose will similarly be raised to 20 mg/day, taken as 10 mg twice a day, and tremor assessed 4 weeks after the last tremor assessment. In the third titration step, the dose will be raised to 30 mg/day, taken as 15 mg twice a day, and tremor assessed at the conclusion of the third titration step. In the fourth titration step, the dose will be raised to 40 mg/day, taken as 20 mg twice a day, and tremor assessed at the conclusion of the fourth titration step. The dose will be adjusted downwards if titration is not tolerated. Subjects who achieve a clinically meaningful tremor reduction will enter a 12-week extension study assessing the stability of the tremor response.
Data analysis: Subjects will be recruited according to a two-part Gehan design. A "responder" is defined as a 30% reduction in the tremor score. To assess whether memantine has a potential responder rate of 30 percent, 9 subjects will be recruited in the first phase. If at least one subject is a responder, another 16 subjects will be recruited to estimate the actual responder rate with a standard error of 10%.
Conclusions: If memantine is effective in suppressing tremor, it would be welcomed by patients and the movement disorders community as a well-tolerated new treatment for essential tremor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential Tremor, Memantine, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memantine
Arm Type
Experimental
Arm Description
Tremor reduction
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Mematine administration
Primary Outcome Measure Information:
Title
The degree of tremor at the end of the dose adjustment phase compared to baseline
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Quality of Life.
Time Frame
Six months
Title
Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Handforth, M.D.
Organizational Affiliation
Veteran Affairs Greater Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
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A Pilot Clinical Trial Of Memantine for Essential Tremor
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