Clinical Trial: A Pilot Clinical Trial Of Memantine for Essential Tremor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Clinical Trial of Memantine for Essential Tremor
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 Summary:
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 wil
Sponsor: VA Greater Los Angeles Healthcare System
Current Primary Outcome: The degree of tremor at the end of the dose adjustment phase compared to baseline [ Time Frame: Six months ]
Original Primary Outcome: The degree of tremor at the end of the dose adjustment phase compared to baseline
Current Secondary Outcome:
- Quality of Life. [ Time Frame: Six months ]
- Degree of tremor at the end of the extension phase compared to the beginning of the extension phase. [ Time Frame: Six months ]
Original Secondary Outcome:
- Quality of Life.
- Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Information By: VA Greater Los Angeles Healthcare System
Dates:
Date Received: February 22, 2007
Date Started: February 2007
Date Completion:
Last Updated: June 20, 2012
Last Verified: June 2012
