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Study of Retigabine Immediate Release as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial-Onset Seizures

NCT01227902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2014-10-17

Study results available
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Summary

The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.

Conditions

Interventions

DRUG

Retigabine IR

Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Belgium
  • Bulgaria
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Thailand
  • Ukraine

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 NCT01227902 on ClinicalTrials.gov