Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

Phase 3

Completed

• Conditions: Epilepsies, Partial; Epilepsy, Complex Partial

• Registration Number: NCT00143143
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Study Completion: 2006-02
• Status Verified: 2006-03
• Last Update Submitted: 2006-07-21
• Last Update Posted: 2006-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Seizure frequency is assessed throughout the study until the study is closed.

Trial Locations

Locations (1)

Pfizer Investigational Site