Retigabine Efficacy and Safety Trial 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 900 mg/day and 600 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

NCT00235755

Run by

GlaxoSmithKline

People needed

539

Starts

2005-12-01

Expected to finish

2008-04-01

Last updated by the study team

2017-04-21

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

• Neurological Clinic-Texas — Dallas, Texas, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• North Coast Neurology Centre — Maroochydore, Queensland, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Austin & Repatriation Medical Centre — West Heidelberg, Victoria, Australia
• A. Z. Middelheim -- Department of Neurology — Antwerp, Belgium
• AZ Sint-Jan — Bruges, Belgium
• Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology — Leuven, Belgium
• Centre Neurologique William Lennox — Ottignies, Belgium
• Hopital Neurologique Pierre Wertheimer — Lyon, Lyonnais, France
• CHU Pontchaillou — Rennes, France
• Hopital Civil de Strasbourg — Strasbourg, France
• Centre Medical de La Teppe — Tain-l'Hermitage, France
• University of Bonn -- Department for Epileptplogy — Bonn, Germany
• Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen — Erlangen, Germany
• Georg-August-Universitaet Goettingen — Göttingen, Germany
• Universitaetsklinik Mainz Neurologische Klinik — Mainz, Germany
• Universitaet Giessen / Marburg Neurologie — Marburg, Germany
• Theatinerstrasse 44 — Munich, Germany
• Universitaetsklinikum Ulm — Ulm, Germany
• Natl. Inst. of Psychiatry and Neurology — Budapest, Hungary
• Orszagos Idegsebeszeti Tudomanyos Intezet — Budapest, Hungary
• Barzilai Medical Center — Ashkelon, Israel
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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