Study in Pediatric Subjects With Epilepsy

Summary

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.

Timeline

Start

2012-07-25

Primary completion

2013-04-29

Completion

2013-04-29

Outcome

Outcome not reported

Stopped: “Terminated after placing the study on hold at the request of the FDA”

Publications

• Background Tompson DJ, Buraglio M, Andrews SM, Wheless JW. Adolescent Clinical Development of Ezogabine/Retigabine as Adjunctive Therapy for Partial-Onset Seizures: Pharmacokinetics and Tolerability. J Pediatr Pharmacol Ther. 2016 Sep-Oct;21(5):404-412. doi: 10.5863/1551-6776-21.5.404.

Drugs

Indications