Status:
COMPLETED
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (1...
Eligibility Criteria
Inclusion
- Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
- Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion
Exclusion
- AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
- Having absences seizures
- Having had status epileptics within the year prior to inclusion
- Having a progressive neurological or systematic disorder
- Having known significant renal or hepatic dysfunction
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00288639
Start Date
December 1 2005
End Date
December 1 2007
Last Update
January 22 2021
Active Locations (8)
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1
Pfizer Investigational Site
Athens, Greece, 11526
2
Pfizer Investigational Site
Athens, Greece, 11527
3
Pfizer Investigational Site
Heraklio, Greece, 71110
4
Pfizer Investigational Site
Mesogion, Athen, Greece, 15125