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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
This Phase 3 study is being conducted in North America, Argentina, and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in total partial seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University of Alabama -- Department of Neurology/Epilepsy Center
Birmingham, Alabama, United States
North Alabama Neuroscience Research Associates
Huntsville, Alabama, United States
Neurology Clinic
Northport, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Clinical Trials Inc.
Little Rock, Arkansas, United States
UCSD Thornton Hospital
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
Delta Waves
Colorado Springs, Colorado, United States
University of Colorado Health Science Center
Denver, Colorado, United States
Start Date
September 1, 2005
Primary Completion Date
January 1, 2008
Completion Date
January 1, 2008
Last Updated
December 8, 2016
306
ACTUAL participants
Retigabine
DRUG
Placebo
DRUG
Lead Sponsor
GlaxoSmithKline
Collaborators
NCT05077904
NCT05667142
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07234695