drugset / Trial / NCT01668654

Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS

NCT01668654 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to \< 18 years old) or Lennox-Gastaut Syndrome (12 to \<30 years old) who have participated in a previous ("parent") study.

Timeline

Start
2012-09-04
Primary completion
2013-06-18
Completion
2013-06-18

Outcome

Outcome not reported

Stopped: “FDA placed a clinical hold on the Pediatric Program requiring retigabine discontinuation in subjects; early termination allows for timely reporting of results.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezogabine Small molecule — —

Indications