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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Epilepsy Mental Retardation Developmental Disabilities

Keywords

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Epilepsy Mental Retardation Developmental Disabilities

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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North Shore Long Island Jewish Health System

Principal Investigators

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Alan Ettinger, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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02.08.035

Identifier Type: -

Identifier Source: org_study_id