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

Phase 3 Terminated 161 enrolled Viatris Inc.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2007-09
Primary completion: 2011-04
Completion: 2011-06

Outcome

Met primary endpoint

Stopped: “See termination reason in detailed description.”

paper was significantly below the 74% and 68% thresholds (p < 0.001 for both). PMID 24415567 ↗

Publications

French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	150 mg	—
Subject	Pregabalin	Small molecule	600 mg	—