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Clinical Trials/NCT00143143
NCT00143143
Completed
Phase 3

Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

Pfizer1 site300 target enrollmentSeptember 2001
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ConditionsEpilepsies, PartialEpilepsy, Complex Partial
DrugsPregabalin

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Epilepsies, Partial
Sponsor
Pfizer
Enrollment
300
Locations
1
Primary Endpoint
Safety assessments are performed at quarterly visits up until the study is closed.
Status
Completed
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Registry
clinicaltrials.gov
Start Date
September 2001
End Date
February 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

Inclusion Criteria

  • •Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
  • •Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
  • •Be currently taking 1 to 3 AEDs.

Exclusion Criteria

  • •Have a treatable cause of seizures
  • •Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

Outcomes

Primary Outcomes

Safety assessments are performed at quarterly visits up until the study is closed.

Secondary Outcomes

  • Seizure frequency is assessed throughout the study until the study is closed.

Study Sites (1)

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