Status:
COMPLETED
Pregabalin Epilepsy Add-On Trial
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Partial Seizures
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subject...
Eligibility Criteria
Inclusion
- Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
- Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures
Exclusion
- Have a treatable cause of seizures
- Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00141258
Start Date
October 1 2005
End Date
August 1 2006
Last Update
January 22 2021
Active Locations (5)
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1
Pfizer Investigational Site
Daegu, South Korea
2
Pfizer Investigational Site
Daejeon, South Korea
3
Pfizer Investigational Site
Gwangju, South Korea
4
Pfizer Investigational Site
Incheon, South Korea