Status:
COMPLETED
Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Eisai Inc.
Conditions:
Epilepsy
Mental Retardation
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the efficacy and tolerability in "real-world" clinical practice, of adjunctive zonisamide treatment in adult patients with developmental disabilities and epileps...
Detailed Description
While a number of randomized double-blind controlled trials have demonstrated the value of zonisamide in the treatment of seizures, such studies lend limited insight into the efficacy and tolerance of...
Eligibility Criteria
Inclusion
- Male or Female, at least 18 years of age
- Diagnosis of mental retardation
- Uncontrolled seizures or intolerable side effects from current AEDs
- Legal guardian is able to consent
Exclusion
- Sulfa allergy
- Prior exposure to zonisamide
Key Trial Info
Start Date :
August 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00298818
Start Date
August 1 2002
End Date
March 1 2008
Last Update
May 20 2008
Active Locations (1)
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1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040