Add on Lacosamide Versus High Dose Monotherapy

Phase 3 Completed 56 enrolled Brigham and Women's Hospital

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.

Timeline

Start: 2011-08-01
Primary completion: 2014-02-15
Completion: 2014-10-21

Outcome

Missed primary endpoint

registry Lacosamide + Low-Dose Levetiracetam vs Control Group (High-Dose Levetiracetam); p = 0.49; Hazard Ratio (HR) 0.76 (95% CI 0.35 to 1.65) NCT01345058 ↗

Publications

Results Lee JW, Alam J, Llewellyn N, Hurwitz S, Bubrick EB, Sarkis RA, Weisholtz D, Yu H, Putta S, Dworetzky BA, Pennell PB. Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures. Clin Neuropharmacol. 2016 May-Jun;39(3):128-31. doi: 10.1097/WNF.0000000000000144.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacosamide	Other / unclassified	100 mg	—
Subject	Levetiracetam	Other / unclassified	—	—