Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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