Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures

Stopped early · Phase 4

Conditions studied: Epilepsies, Partial

In brief

To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five, AEDs.

Key facts

Study ID

NCT00215215

Run by

Cyberonics, Inc.

People needed

360

Starts

2005-02-01

Expected to finish

2007-11-01

Last updated by the study team

2006-02-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has a diagnosis of partial seizures with onset before age 50, and the patient's prior electroencephalography and magnetic resonance imaging studies are consistent with the diagnosis of partial seizures.
• Patient has at least 4 complex partial seizures, but less than 25 seizures (any type), per month during the 3 months preceding randomization; for the 8 weeks preceding randomization, the seizure frequency should be confirmed from a patient diary.
• Patient has not had an adequate response to an adequate dosage of -- or was intolerant to -- a minimum of 2 different AEDs.
• Patient has (in the investigator's judgment) sufficient impairment from his/her epilepsy and/or epilepsy treatment that the potential benefits/risks of VNS therapy are warranted.
• Patient must currently be receiving at least one AED, but not more than three AEDs, in a stable dosage regimen for at least one month before randomization.
• Patient must be 12 years of age or older.
• Patient must be able to provide reliable seizure counts and to complete the evaluations specified in the study procedures flow chart.
• Patient must provide written informed consent, or legal guardian must give written permission and the minor provide written assent.

You may not qualify if…

• Patient has a history (lifetime) of having received more than 5 different AEDs.
• Patient has had a bilateral or left cervical vagotomy.
• Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
• Patient is expected to require full body magnetic resonance imaging during the clinical study.
• Patient has had a previous VNS Therapy System implant.
• Patient has a previous neuroimaging study that demonstrates mesial temporal sclerosis, cortical dysplasia, or a suspected brain tumor.

Where it is running

• Bronislav Shafran, M.D., P.C. — Phoenix, Arizona, United States
• Xenoscience — Phoenix, Arizona, United States
• Dedicated Clinical Research, Inc. — Sun City, Arizona, United States
• USC Comprehensive Epilepsy Center — Los Angeles, California, United States
• Certified Clinical Research — Roseville, California, United States
• Pediatric Diagnostic Center — Ventura, California, United States
• University of Florida, Department of Neurology — Gainesville, Florida, United States
• Neurology Associates, P.A. — Maitland, Florida, United States
• Child Neurology Center of Northwest Florida — Pensacola, Florida, United States
• Pediatric Neurology of Idaho — Boise, Idaho, United States
• Freeport Health Network, Department of Neurology — Freeport, Illinois, United States
• Wayne State University School of Medicine, Department of Neurology — Detroit, Michigan, United States
• Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center — New York, New York, United States
• William Huffstutter, M.D. — Asheville, North Carolina, United States
• Medford Neurological and Spine Clinic — Medford, Oregon, United States
• Neurology and Sleep Medicine — Bethlehem, Pennsylvania, United States
• Mid-South Physicians Group, P.L.L.C. — Germantown, Tennessee, United States
• Hermann Hospital, UT Comprehensive Epilepsy Center — Houston, Texas, United States
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States
• Texas Association of Pediatric Neurology — San Antonio, Texas, United States
• Pivotal Research Centers — Midvale, Utah, United States
• Pharmaceutical Research Organization — South Ogden, Utah, United States
• Regional Epilepsy Center Saint Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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