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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298818
• Other study ID #: 02.08.035
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: May 19, 2008
• Start date: August 2002
• Est. completion date: March 2008

Study information

• Verified date: May 2008
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Developmental Disabilities
• Epilepsy
• Intellectual Disability
• Mental Retardation

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Eisai Inc.

Country where clinical trial is conducted

United States,