Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223743
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2005-09-15
Brief Title:
A SafetyEfficacy Trial of Zonisamide for Essential Tremor
Sponsor:
VA Greater Los Angeles Healthcare System
Organization:
VA Greater Los Angeles Healthcare System
Study Overview
Official Title:
Novel Therapies for Essential Tremor - Zonisamide Pilot Study
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 pilot study is to obtain information whether the medication zonisamide reduces tremor in persons with essential tremor and is well tolerated
Detailed Description:
Essential tremor is common affecting about four percent of the population above age 40 years Of these about half have troublesome tremor that warrants medical therapy but only half of these find satisfactory treatment Thus it can be estimated that about one million Americans have not been able to find adequate therapy for their essential tremor Presently used medications may fail due to lack of efficacy or tolerance After encountering anecdotal experience of zonisamides efficacy for essential tremor we decided to conduct a single-site open-treatment rising-dose study with blinded videotape ratings of tremor Zonisamide is presently on the market in the United States for epilepsy Its use in other conditions is experimental
Healthy participants with bilateral hand tremor will initially sign an IRB-approved informed consent form then have assessments in a Screening Visit to determine that they are healthy physical and neurological examinations routine blood tests electrocardiogram and tremor assessments with rating scales Tremor at each visit will be videotaped as well as assessed openly by a rater If participants meet eligibility criteria they will return to a Baseline Visit Visit 1 for repeat tremor assessment and the initial dispensation of zonisamide
The study drug initially will taken as one 50-mg tablet a day then the dose increased by one tablet each two weeks to no more than 3 tablets 150 mg taken twice a day During this 12-week dose adjustment phase the participant will be seen in clinic each 4 weeks for tremor assessments and review of health status In addition the participant will be contacted by telephone each week If any symptom occurs suggestive of side effects the escalation will be stopped or the dose reduced in order to resolve the symptom
At the end of the 12-week dose adjustment phase at Visit 4 it will be determined whether meaningful tremor reduction has occurred at the target dose of 300 mg per day or at a lesser but tolerated dose If not the participant will discontinue from the study If benefit has occurred the subject will be invited to continue taking zonisamide for another 12 weeks at the conclusion of which the participant will be seen in the final visit Visit 5
The videotapes will be coded so that the order they were made is not apparent and the degree of tremor will be rated by a rater who does not know the study participants
Healthy participants with bilateral hand tremor will initially sign an IRB-approved informed consent form then have assessments in a Screening Visit to determine that they are healthy physical and neurological examinations routine blood tests electrocardiogram and tremor assessments with rating scales Tremor at each visit will be videotaped as well as assessed openly by a rater If participants meet eligibility criteria they will return to a Baseline Visit Visit 1 for repeat tremor assessment and the initial dispensation of zonisamide
The study drug initially will taken as one 50-mg tablet a day then the dose increased by one tablet each two weeks to no more than 3 tablets 150 mg taken twice a day During this 12-week dose adjustment phase the participant will be seen in clinic each 4 weeks for tremor assessments and review of health status In addition the participant will be contacted by telephone each week If any symptom occurs suggestive of side effects the escalation will be stopped or the dose reduced in order to resolve the symptom
At the end of the 12-week dose adjustment phase at Visit 4 it will be determined whether meaningful tremor reduction has occurred at the target dose of 300 mg per day or at a lesser but tolerated dose If not the participant will discontinue from the study If benefit has occurred the subject will be invited to continue taking zonisamide for another 12 weeks at the conclusion of which the participant will be seen in the final visit Visit 5
The videotapes will be coded so that the order they were made is not apparent and the degree of tremor will be rated by a rater who does not know the study participants
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