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Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

NCT00310375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2020-07-31

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Conditions

Interventions

DRUG

Ezogabine: USAN Retigabine (International Nonproprietary Name)

Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-01
Primary Completion
2016-11-30
Completion
2017-03-15

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00310375 on ClinicalTrials.gov