drugset / Trial / NCT01668654
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezogabine | Small molecule | — | — |