NCT00537940

Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures

A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.

Conditions

• Epilepsy
• Partial Seizure Disorder
• Epilepsies, Partial
• Complex Partial Seizure Disorder

Interventions

Type	Name	Description
DRUG	Pregabalin	150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
DRUG	Gabapentin	300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2007-10-02
• Last updated: 2021-01-22
• Results posted: 2014-08-08

Locations

8 sites across 4 countries: Costa Rica, El Salvador, Guatemala, Peru