Zonisamide in the Treatment of Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616343
Recruitment Status : Terminated (Principal Investigator left the study site on December 28, 2012.)
First Posted : February 15, 2008
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Information provided by (Responsible Party):
Loma Linda University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Essential Tremor
Intervention: Drug: Zonisamide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
•<=18 years Male/Female Hx essential tremor

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 66.1  (16.33078) 
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   5 
[Units: Participants]
Female   3 
Male   6 
Region of Enrollment 
[Units: Participants]
United States   9 

  Outcome Measures

1.  Primary:   Tremor Severity   [ Time Frame: 4 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
PI has left the institution and we are unable to accurately assess the data from the remaining records.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. David Swope
Organization: Loma Linda University
phone: 909-558-4908

Responsible Party: Loma Linda University Identifier: NCT00616343     History of Changes
Other Study ID Numbers: OSR#53157
First Submitted: February 4, 2008
First Posted: February 15, 2008
Results First Submitted: June 12, 2014
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014