Essential TremorNCT00616343
Zonisamide in the Treatment of Essential Tremor
A study testing Zonisamide in people with Essential Tremor, run by Loma Linda University.
Trial summary
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor. 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
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
- Age: 18 years or over.
- Willingness and ability to comply with the study requirements and give informed consent.
Who cannot join
- Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
- Known alcohol or substance abuse in previous 12 months.
- Positive pregnancy test.
- Unwillingness to use adequate contraceptive methods if of childbearing potential.
- Known allergy to sulfonamides.
- Laboratory abnormalities prior to onset of trial.
About this study
Official title: Pilot Study of Zonisamide in the Treatment of Essential Tremor
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.
Read the detailed description
The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.
- Conditions
- Essential Tremor
- Being tested
- Zonisamide
- Keywords
- ET
- 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
Also called Zonegran
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide | Active comparator | Not described Receives: Drug: Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Severity
PI has left the institution and we are unable to accurately assess the data from the remaining records.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJun 2003
- Primary completionOct 2012
- Study completionDec 2012
Why it stopped: Principal Investigator left the study site on December 28, 2012.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Swope, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616343
- Sponsor's protocol ID
- OSR#53157
- Status last verified
- Jul 2014
- First submitted
- 4 Feb 2008
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Zonisamide in the Treatment of Essential Tremor
- ClinicalTrials.gov ID
- NCT00616343
- Acronym / sponsor ID
- OSR#53157
- Conditions
- Essential Tremor
- Keywords
- ET
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the study site on December 28, 2012.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 17 Jul 2014
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 study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.
Detailed description
The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zonisamide | Active comparator | Drug: Zonisamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
- Age: 18 years or over.
- Willingness and ability to comply with the study requirements and give informed consent.
Key exclusion criteria (6 listed)
- Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
- Known alcohol or substance abuse in previous 12 months.
- Positive pregnancy test.
- Unwillingness to use adequate contraceptive methods if of childbearing potential.
- Known allergy to sulfonamides.
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 |
|---|---|---|
| ZonisamideAlso: Zonegran100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks. | Drug | Zonisamide |
Primary outcome
Tremor Severity
Time frame: 4 weeks
PI has left the institution and we are unable to accurately assess the data from the remaining records.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David M Swope, MD principal investigator
Loma Linda University
Questions about this trial
What is this clinical trial studying?
A study testing Zonisamide in people with Essential Tremor, run by Loma Linda University.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tremor Severity (time frame: 4 weeks). 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 17 Jul 2014.