Zonisamide in the Treatment of Essential Tremor

This study has been terminated.
(Principal Investigator left the study site on December 28, 2012.)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616343
First received: February 4, 2008
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: June 12, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Essential Tremor
Intervention: Drug: Zonisamide

  Participant Flow
  Hide 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
  Description
Zonisamide Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.

Participant Flow:   Overall Study
    Zonisamide  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
  Description
Zonisamide Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.

Baseline Measures
    Zonisamide  
Number of Participants  
[units: participants]
  9  
Age  
[units: Years]
Mean ± Standard Deviation
  66.1  ± 16.33078  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     5  
Gender  
[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
  Hide 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
  Hide 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
e-mail: Thamilton@llu.edu


No publications provided


Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616343     History of Changes
Other Study ID Numbers: OSR#53157
Study First Received: February 4, 2008
Results First Received: June 12, 2014
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board