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

Epilepsies, Partial Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00215215
• Other study ID #: E-20
• Status: Terminated
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: February 20, 2006
• Start date: February 2005
• Est. completion date: November 2007

Study information

• Verified date: February 2006
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial

Intervention

Device:
• Vagus Nerve Stimulation Therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Fisher RS, Handforth A. Reassessment: vagus nerve stimulation for epilepsy: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 1999 Sep 11;53(4):666-9. — View Citation

Heck C, Helmers SL, DeGiorgio CM. Vagus nerve stimulation therapy, epilepsy, and device parameters: scientific basis and recommendations for use. Neurology. 2002 Sep 24;59(6 Suppl 4):S31-7. Review. — View Citation

Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology. 2002 Sep 24;59(6 Suppl 4):S26-30. — View Citation

Schachter SC. Vagus nerve stimulation therapy summary: five years after FDA approval. Neurology. 2002 Sep 24;59(6 Suppl 4):S15-20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	*Quality of Life in Epilepsy Questionnaire (QOLIE)
Primary	at baseline, Week 26 and Week 52.
Primary	*Patients will be asked to keep a daily record of their seizures in a seizure diary supplied by the investigational sites.
Secondary	The QOLIE at baseline, Week 26 and Week 52.
Secondary	*Percentage Change in Seizure-Related Disability Assessment Scale (SERDAS)at baseline and Week 52 for each patient.
Secondary	*Percentage Change in Hospital Anxiety and Depression Scale (HAD)at baseline and Week 52 for each patient.
Secondary	*Over the course of the study, AED medications will be assessed.
Secondary	*Patient Satisfaction Survey will be performed at Week 52.