Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298818
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2006-03-02
Brief Title:
Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation Developmental Disabilities
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MRDD observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing antiepileptic drugs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None