Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures

PHASE4TerminatedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2010

Conditions
Epilepsy
Interventions
DEVICE

Vagus Nerve Stimulation (VNS) Therapy

Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.

DRUG

Anti-Epileptic Drug (AED)

Subject has tried at least 2 appropriate AEDs tested to tolerance or to blood levels at upper end of the target range of which at least 2 had been tolerated at normal doses.

Trial Locations (19)

Unknown

Medical University of Vienna - Vienna General Hospital (AKH), Vienna

ULB- Hospital Erasme, Brussels

Kinderklinik der Justus-Liebig Universität, Giessen

University Children's Hospital, Lübeck

University Hospital Lund, Lund

Astrid Lindgrens Barnsjukhus Karolinska, Stockholm

Uppsala University Hospital, Uppsala

Birmingham Children's Hospital, Birmingham

Royal Hospital for Sick Children, Bristol

Addenbrookes Hospital, Cambridge

Ninewells Hospital & Medical School, Dundee

Leeds General Infirmary, Leeds

Great Ormond Street Hospital for Children, London

King's College Hospital, London

Royal Manchester Children's Hospital, Manchester

Sir James Spence Institute - Royal Victoria Infirmary, Newcastle

Queens's Medical Centre Nottingham, Nottingham

Sheffield Children's Hospital, Sheffield

Southampton Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cyberonics, Inc.

INDUSTRY