CClinicalTrials.gg
TerminatedNCT00616343Updated Jul 17, 2014Results posted

Zonisamide in the Treatment of Essential Tremor

An interventional study of Zonisamide in Essential Tremor, sponsored by Loma Linda University. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-17.

Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment

Why this study was terminated
Principal Investigator left the study site on December 28, 2012.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Essential Tremor

Keywords

  • ET
03

In context

Tremor

257 studies on the registry are indexed under Tremor; 59 are open to participants now.

This study's enrollment of 9 is below the median of 25 across 184 interventional studies indexed under Tremor.

Browse Tremor studies →

Lead sponsor

Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
  2. Age: 18 years or over.
  3. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
  2. Known alcohol or substance abuse in previous 12 months.
  3. Positive pregnancy test.
  4. Unwillingness to use adequate contraceptive methods if of childbearing potential.
  5. Known allergy to sulfonamides.
  6. Laboratory abnormalities prior to onset of trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • Active comparator
    Zonisamide

    Drug: Zonisamide

Interventions

  • DrugZonisamide

    100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.

    Also known as: Zonegran

06

What researchers measure

Primary outcomes

  1. Tremor Severity

    PI has left the institution and we are unable to accurately assess the data from the remaining records.

    Time frame: 4 weeks

07

Results

Posted Jul 17, 2014
Limitations and caveats
PI has left the institution and we are unable to accurately assess the data from the remaining records.

Participant flow

Participant flow — Overall Study
MilestoneZonisamide
Started9
Completed9
Not completed0

Outcome measures

PrimaryTremor Severity

PI has left the institution and we are unable to accurately assess the data from the remaining records.

Time frame:
4 weeks

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Zonisamide—0/9 (0%)0/9 (0%)

Baseline characteristics

•\<=18 years Male/Female Hx essential tremor

Age, Continuous
Age, Continuous(Years)Zonisamide
Mean66.1 ± 16.33078
Age, Categorical
Age, Categorical(Participants)Zonisamide
<=18 years0
Between 18 and 65 years4
>=65 years5
Sex: Female, Male
Sex: Female, Male(Participants)Zonisamide
Female3
Male6
Region of Enrollment
Region of Enrollment(participants)Zonisamide
United States9
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00616343
Lead sponsor
Loma Linda University
Responsible party
Sponsor
First posted
Feb 15, 2008
Start date
Jun 2003
Primary completion
Oct 2012
Completion
Dec 2012
Results posted
Jul 17, 2014
Last update
Jul 17, 2014

Study contacts

David M Swope, MD
principal investigator · Loma Linda University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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