Status:
TERMINATED
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Partial Seizures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (...
Detailed Description
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling ...
Eligibility Criteria
Inclusion
- Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.
Exclusion
- Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00407797
Start Date
March 1 2007
End Date
August 1 2009
Last Update
January 25 2021
Active Locations (8)
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1
Pfizer Investigational Site
México, D. F., Mexico, CP 06700
2
Pfizer Investigational Site
Acapulco de Juárez, Guerrero, Mexico, 39670
3
Pfizer Investigational Site
Morelia, Michoacán, Mexico, CP 58000
4
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico, 64060