Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
NCT01668654 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2020-10-30
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.
Conditions
Interventions
- DRUG
-
retigabine/ezogabine
retigabine/ezogabine will be administered three times a day (TID) as add-on therapy based on weight
Sponsors & Collaborators
-
Bausch Health Americas, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 29 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-09-04
- Primary Completion
- 2013-06-18
- Completion
- 2013-06-18
Countries
- United States
Study Locations
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