Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

Phase 1 Completed 60 enrolled UCB Pharma

RandomizedCrossoverDouble-blind

Summary

The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.

Timeline

Start: 2012-05
Primary completion: 2014-01
Completion: 2014-01

Outcome

Met primary endpoint

paper Carbamazepine immediate-release had worse scores compared with LCM for the primary composite neuropsychological outcome (mean difference=0.33 [SD: 1.36], p=0.011) PMID 27517350 ↗

Publications

Meador KJ, Loring DW, Boyd A, Echauz J, LaRoche S, Velez-Ruiz N, Korb P, Byrnes W, Dilley D, Borghs S, De Backer M, Story T, Dedeken P, Webster E. Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine. Epilepsy Behav. 2016 Sep;62:267-75. doi: 10.1016/j.yebeh.2016.07.007. Epub 2016 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carbamazepine	Small molecule	200 mg	Oral
Subject	Lacosamide	Other / unclassified	150 mg	Oral

Indications

No indication recorded.