Essential TremorPhase 2NCT00223743
A Safety/Efficacy Trial of Zonisamide for Essential Tremor
A Phase 2 study testing Zonisamide in people with Essential Tremor, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Zonisamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- diagnosis of essential tremor
- tremor present in both hands for at least one year
- tremor is bothersome in at least one hand, so that reduction of tremor would improve quality of life
- able to comply with study visits and procedures
- has voluntarily signed consent form
- able to abstain from alcohol for 12 hours prior to each visit, and from caffeine on day prior to visit
- taking no medications or stable doses of anti-tremor medication for 4 weeks prior to the Baseline visit
Who cannot join
- medical condition likely to cause hospitalization during the study
- progressive neurological disorder other than essential tremor
- history of serious psychiatric illness
- history of drug or alcohol abuse in past year
- consumes more than two glasses of wine or equivalent per day
- has received botulinum toxin injection in past 6 months
Show all 17Show fewer
- currently using experimental device
- has taken experimental drug within 5 half lives of its elimination
- has received deep brain stimulation in past two weeks or has potential need for this therapy during the study
- thalamotomy within the past 6 months
- taking medications judged by investigator to exacerbate tremor
- has probable cause of tremor other than essential tremor
- condition likely to interfere with absorption, metabolism or elimination of study drug
- hepatic disease
- renal disease
- history of renal stones
- history of allergy to sulfonamides
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles
Los Angeles, California, 90073
About this study
Official title: Novel Therapies for Essential Tremor - Zonisamide Pilot Study
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.
Read the 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 zonisamide's 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.
- Conditions
- Essential Tremor
- Being tested
- Zonisamide
- Keywords
- essential tremor, zonisamide, clinical trial
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide | Experimental | Zonisamide administration and tremor assessment to assess efficacy in reducing essential tremor Receives: Drug: Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of tremor at the end of the dose adjustment phase compared to baseline.
Measured: 3 months
Secondary outcomes (2)
Quality of life.
Measured: 6 months
Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Ralph M. Parsons Foundation
- Responsible party
- Principal investigator, Adrian Handforth, MD, VA Greater Los Angeles Healthcare System
- Investigators
- Adrian Handforth, M.D., Principal investigator, Veterans Affairs Greater Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223743
- Sponsor's protocol ID
- 0030
- Status last verified
- Jun 2012
- First submitted
- 15 Sep 2005
- Last updated
- 22 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Therapies for Essential Tremor - Zonisamide Pilot Study
- ClinicalTrials.gov ID
- NCT00223743
- Acronym / sponsor ID
- 0030
- Conditions
- Essential Tremor
- Keywords
- essential tremor, zonisamide, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- Ralph M. Parsons Foundation
- Study start
- Nov 2004
- Primary completion
- Sep 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 zonisamide's 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zonisamide | Experimental | Drug: ZonisamideZonisamide administration and tremor assessment to assess efficacy in reducing essential tremor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18 or older
- diagnosis of essential tremor
- tremor present in both hands for at least one year
- tremor is bothersome in at least one hand, so that reduction of tremor would improve quality of life
- able to comply with study visits and procedures
Key exclusion criteria (17 listed)
- medical condition likely to cause hospitalization during the study
- progressive neurological disorder other than essential tremor
- history of serious psychiatric illness
- history of drug or alcohol abuse in past year
- consumes more than two glasses of wine or equivalent per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamidestudy 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. | Drug | Zonisamide |
Primary outcome
The degree of tremor at the end of the dose adjustment phase compared to baseline.
Time frame: 3 months
2 secondary outcomes
Quality of life.
Time frame: 6 months
Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Handforth, M.D. principal investigator
Veterans Affairs Greater Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zonisamide in people with Essential Tremor, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of tremor at the end of the dose adjustment phase compared to baseline. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.