Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439699
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2007-02-22
Brief Title:
A Pilot Clinical Trial Of Memantine for Essential Tremor
Sponsor:
VA Greater Los Angeles Healthcare System
Organization:
VA Greater Los Angeles Healthcare System
Study Overview
Official Title:
A Pilot Clinical Trial of Memantine for Essential Tremor
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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 mgday 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 mgday 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 mgday 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
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 mgday 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 mgday 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 mgday 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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None