Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

Completed · Phase 3 · Has a placebo group

Conditions studied: Seizures

In brief

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).

Key facts

Study ID

NCT00232596

Run by

GlaxoSmithKline

People needed

306

Starts

2005-09-01

Expected to finish

2008-01-01

Last updated by the study team

2016-12-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
• 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
• Currently treated with up to three established AEDs
• Vagal Nerve Stimulator may be included

You may not qualify if…

• Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
• Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests
• Impaired renal function (creatinine clearance less than 50 mL/minute)
• Evidence of progressive central nervous disease, lesion, or encephalopathy
• History of primary generalized seizures
• History of clustering or flurries or status epilepticus within 12 months of study entry

Where it is running

• 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
• University of Florida -- Shands Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Lovelace Scientific Resources — Sarasota, Florida, United States
• McFarland Clinic — Ames, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Epilepsy Group, P.A. — Saint Paul, Minnesota, United States
• The Comprehensive Epilepsy Care Center for Children and Adults — Chesterfield, Missouri, United States
• Beth Israel Medical Center — New York, New York, United States
• Asheville Neurology Specialists — Asheville, North Carolina, United States
• Medical University of Ohio at Toledo — Toledo, Ohio, United States
• Oregon Neurology PC — Tualatin, Oregon, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Alabama -- Department of Neurology/Epilepsy Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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