Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056576
Status:
COMPLETED
Last Update Posted:
2011-07-18
First Post:
2003-03-18
Brief Title:
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Double-Blind Randomized Multicenter Parallel Group Study to Establish Dose-Response Safety and Efficacy of Zonegran Zonisamide as Monotherapy in Patients With Newly Diagnosed Epilepsy
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases
Detailed Description:
Epilepsy is characterized by repeated seizures caused by recurrent abnormal and excessive synchronous discharges from cerebral neurons Seizures may be triggered by various causes such as CNS infections fever tumors toxins vascular disease degenerative disease trauma or may be idiopathic The type of seizure is usually defined by the initial event the duration alterations of consciousness patterns of motor activity and post-ictal symptoms In addition certain seizure types have characteristic EEG patterns The International Classification of Epileptic Seizures classifies seizures as partial or generalized Partial seizures are further classified as simple partial complex partial impaired consciousness or partial seizures secondarily generalized All partial seizures have onset in a discrete cortical region Generalized seizures are bilaterally symmetrical and without focal onset and include absence seizures myoclonic seizures clonic seizures tonic seizures tonic-clonic seizures and atonic seizures The goals of treatment include the prevention of seizures medical management of seizures and management of the consequences of epilepsy The study will be conducted with patients who have new onset epilepsy characterized by complex partial seizures and will attempt to characterize the relationship between zonisamide dose and seizure prevention and demonstrate monotherapy efficacy
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