Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation
Information source: North Shore Long Island Jewish Health System
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Mental Retardation; Developmental Disabilities
Phase: Phase 4
Status: Completed
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Alan Ettinger, MD, Principal Investigator, Affiliation: North Shore Long Island Jewish Health System
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.
Clinical Details
Official title: Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation / Developmental Disabilities
Study design: Case-Only, Prospective
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
Additional Information
Starting date: August 2002
Ending date: March 2008
Last updated: May 19, 2008
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