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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00298818
Enrollment
25
Registered
2006-03-03
Start date
2002-08-31
Completion date
2008-03-31
Last updated
2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Disabilities, Epilepsy, Mental Retardation

Keywords

Epilepsy, Mental Retardation, Developmental Disabilities

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.

Interventions

None listed

Sponsors

Eisai Inc.
CollaboratorINDUSTRY
Northwell Health
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026