Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cyberonics, Inc.

Criteria

Inclusion Criteria:

• Patient has confirmed partial onset seizures.

• Seizure activity is not adequately controlled by patient's current AED regimen.

• Patient is between 16 and 75 years of age.

• Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance.

• Patient has previously failed at least 3 AEDs in single or combination use.

• During baseline evaluation period, patient should take at least 1 AED.

• Patient should have confirmed epilepsy for a minimum of 2 years.

• Patient's AED regimen is stable for at least 1 month prior to enrolment.

• Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment.

• Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.

Exclusion Criteria:

• Patient has pseudoseizures or a history of pseudoseizures.

• Patient has idiopathic generalised epilepsy or unclassified epilepsy.

• Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy.

• Patient has had a unilateral or bilateral cervical vagotomy.

• Patient has a history of non-compliance with the completion of a seizure diary.

• Patient has taken an investigational drug within a period of 3 months prior to inclusion.

• Patient is currently using another investigational medical device.

• Patient has a significant cardiac or pulmonary condition currently under treatment.

• Patient has previously undergone brain surgery.

• Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator.

• Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.