Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165828
Status:
TERMINATED
Last Update Posted:
2014-06-27
First Post:
2005-09-13
Brief Title:
Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
Sponsor:
Eisai GmbH
Organization:
Eisai Inc
Study Overview
Official Title:
Randomized Trial to Assess Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
Status:
TERMINATED
Status Verified Date:
2013-11
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:
Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study provided that they fulfill all inclusion criteria and none of the exclusion criteria Following a baseline phase of 8 weeks duration the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B respectively After eight weeks of treatment the daily dose in group A can be increased to 300 mg in case of insufficient efficacy Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase if applicable and after 4 8 12 and 16 weeks At the end of the first second and third treatment week and at the end of week six the patient is additionally contacted by telephone Efficacy and safety parameters are assessed at baseline during all control visits and at the end of the study
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-000260-57 | EUDRACT_NUMBER | None | None |