Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034814
Status:
COMPLETED
Last Update Posted:
2011-03-17
First Post:
2002-05-02
Brief Title:
Multicenter Trial for Adults With Partial Seizures
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures A Phase II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2011-03
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:
To compare seizure frequency in patients with refactory partial seizures with or without generalization who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs AEDs and to determine the safety of Talampanel in this group of patients
Detailed Description:
A randomized double-blind placebo controlled multicenter efficacy and safety study of talampanel TLP in 190 patients 18-65 years old with refractory partial seizures
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