NCT00407797

Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).

Detailed description

This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.

Conditions

• Partial Seizures

Interventions

Type	Name	Description
DRUG	Pregabalin	150 to 600 mg/day during 21 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-12-05
• Last updated: 2021-01-25
• Results posted: 2010-09-09

Locations

8 sites across 1 country: Mexico