drugset / Trial / NCT00407797

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

NCT00407797 ↗

Phase 4 Terminated 136 enrolled Viatris Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start
2007-03
Primary completion
2009-08
Completion
2009-08

Outcome

Met primary endpoint

registry analysis (unspecified test); Pregabalin; p <.0001; t-test, 2 sided NCT00407797 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 150 mg —
Subject Pregabalin Small molecule 300 mg —
Subject Pregabalin Small molecule 600 mg —

Indications