NCT00616343

Brief Summary

The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 17, 2014

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

9.3 years

First QC Date

February 4, 2008

Results QC Date

June 12, 2014

Last Update Submit

July 16, 2014

Conditions

Essential Tremor

Keywords

ET

Outcome Measures

Primary Outcomes (1)

  • Tremor Severity

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

    4 weeks

Study Arms (1)

Zonisamide

ACTIVE COMPARATOR
Drug: Zonisamide

Interventions

ZonisamideDRUG

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

Also known as: Zonegran
Zonisamide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential Tremor

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

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

Results Point of Contact

Title
Dr. David Swope
Organization
Loma Linda University
Thamilton@llu.edu
909-558-4908

Study Officials

  • David M Swope, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

June 1, 2003

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

July 17, 2014

Results First Posted

July 17, 2014

Record last verified: 2014-07