Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation

Completed

• Conditions: Epilepsy; Mental Retardation; Developmental Disabilities

• Registration Number: NCT00298818
• Lead Sponsor: Northwell Health

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 epilepsy.

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 zonisamide in real-world clinical practice. Furthermore, randomized trials tend to inquire about negative effects, such as adverse reactions, while positive effects such as improvement in mood, or sense of well-being are not similarly categorized. In addition, there is little information about experience with zonisamide specifically in adult patients with mental retardation (MR) / developmental disabilities (DD). Anecdotal experience suggests that zonisamide is exceptionally well-tolerated, and is associated with an improved general sense of well-being and quality of life in non-DD patients. In patients with MR/DD, observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing antiepileptic drugs.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-12
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-03
• Study Completion: 2008-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-19
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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 Criteria

• Sulfa allergy
• Prior exposure to zonisamide

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States