Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation / Developmental Disabilities|
|Study Start Date:||August 2002|
|Study Completion Date:||March 2008|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298818
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Alan Ettinger, MD||North Shore Long Island Jewish Health System|