NCT00524030

Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Detailed description

After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	pregabalin 600 mg/day	pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
DRUG	pregabalin 150 mg/day	pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2007-09-03
• Last updated: 2021-01-20
• Results posted: 2012-05-10

Locations

73 sites across 4 countries: United States, Czechia, Hong Kong, Ukraine