NCT00298818

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
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Mental Retardation
• Developmental Disabilities

Timeline

• Start date: 2002-08-01
• Primary completion: 2005-12-01
• Completion: 2008-03-01
• First posted: 2006-03-03
• Last updated: 2008-05-20

Locations

1 site across 1 country: United States