Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372528
Status:
TERMINATED
Last Update Posted:
2021-01-26
First Post:
2006-09-05
Brief Title:
An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
An Open-Label Multi-Center Add-On Study Of Pregabalin LYRICA In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010 1008-035 1008-114 Or 1008-164
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated on April 8 2011 as Pfizer Canada could no longer supply study drug No efficacy or safety concerns factored into this decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010 1008-035 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mgday to 600 mgday in Canadian subjects with refractory partial seizures
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