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

Study results available
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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
  • GlaxoSmithKline

    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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668654 on ClinicalTrials.gov