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

Sponsor

Cyberonics, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00215215

Collaborator

(none)

360

Enrollment

Locations

Duration (Months)

15.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsies, Partial	Device: Vagus Nerve Stimulation Therapy	Phase 4

Detailed Description

Published data suggest that patients who continue to experience seizures after trials of two or three AEDs are unlikely to become seizure-free with further attempts at pharmacotherapy. Such patients may experience poor quality of life and functional outcomes from continuing seizures and the adverse effects associated with further attempts at pharmacotherapy. VNS is a non-pharmacologic treatment for epilepsy with well-established effectiveness as an adjunctive treatment (to AEDs) for partial seizures refractory to AEDs, but there are no randomized clinical trials comparing the effectiveness of adjunctive VNS therapy with further pharmacotherapy alone in such patients.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Post Marketing Study; Randomized, Parallel-Group Comparison of Treatment With Pharmacotherapy or Adjunctive Vagus Nerve Stimulation Therapy for Pharmacoresistant Partial Seizures: A Large Simple Effectiveness Trial

Study Start Date :

Feb 1, 2005

Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

*Quality of Life in Epilepsy Questionnaire (QOLIE) []
at baseline, Week 26 and Week 52. []
*Patients will be asked to keep a daily record of their seizures in a seizure diary supplied by the investigational sites. []

Secondary Outcome Measures

The QOLIE at baseline, Week 26 and Week 52. []
*Percentage Change in Seizure-Related Disability Assessment Scale (SERDAS)at baseline and Week 52 for each patient. []
*Percentage Change in Hospital Anxiety and Depression Scale (HAD)at baseline and Week 52 for each patient. []
*Over the course of the study, AED medications will be assessed. []
*Patient Satisfaction Survey will be performed at Week 52. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bronislav Shafran, M.D., P.C.	Phoenix	Arizona	United States	85003
2	Xenoscience	Phoenix	Arizona	United States	85013
3	Dedicated Clinical Research, Inc.	Sun City	Arizona	United States	85351
4	USC Comprehensive Epilepsy Center	Los Angeles	California	United States	90033
5	Certified Clinical Research	Roseville	California	United States	95661
6	Pediatric Diagnostic Center	Ventura	California	United States	93003
7	University of Florida, Department of Neurology	Gainesville	Florida	United States	32610
8	Neurology Associates, P.A.	Maitland	Florida	United States	32751
9	Child Neurology Center of Northwest Florida	Pensacola	Florida	United States	32504
10	Pediatric Neurology of Idaho	Boise	Idaho	United States	83712
11	Freeport Health Network, Department of Neurology	Freeport	Illinois	United States	61032
12	Wayne State University School of Medicine, Department of Neurology	Detroit	Michigan	United States	48201
13	Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center	New York	New York	United States	10021
14	William Huffstutter, M.D.	Asheville	North Carolina	United States	28801
15	Medford Neurological and Spine Clinic	Medford	Oregon	United States	997504
16	Neurology and Sleep Medicine	Bethlehem	Pennsylvania	United States	18015
17	Mid-South Physicians Group, P.L.L.C.	Germantown	Tennessee	United States	38138
18	Hermann Hospital, UT Comprehensive Epilepsy Center	Houston	Texas	United States	77030
19	Texas Tech University Health Sciences Center	Lubbock	Texas	United States	79430
20	Texas Association of Pediatric Neurology	San Antonio	Texas	United States	78258
21	Pivotal Research Centers	Midvale	Utah	United States	84047
22	Pharmaceutical Research Organization	South Ogden	Utah	United States	84403
23	Regional Epilepsy Center Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215