Epilepsies, PartialPhase 4NCT00215215
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
A Phase 4 study testing Vagus Nerve Stimulation Therapy in people with Epilepsies, Partial, run by Cyberonics, Inc. at 23 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Vagus Nerve Stimulation Therapy
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- 23 sitesUnited States
- Study dates
- Feb 2005to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
William Huffstutter, M.D.
Asheville, North Carolina, 28801
Neurology and Sleep Medicine
Bethlehem, Pennsylvania, 18015
Pediatric Neurology of Idaho
Boise, Idaho, 83712
Wayne State University School of Medicine, Department of Neurology
Detroit, Michigan, 48201
Freeport Health Network, Department of Neurology
Freeport, Illinois, 61032
University of Florida, Department of Neurology
Gainesville, Florida, 32610
Mid-South Physicians Group, P.L.L.C.
Germantown, Tennessee, 38138
Hermann Hospital, UT Comprehensive Epilepsy Center
Houston, Texas, 77030
USC Comprehensive Epilepsy Center
Los Angeles, California, 90033
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Neurology Associates, P.A.
Maitland, Florida, 32751
Medford Neurological and Spine Clinic
Medford, Oregon, 997504
Pivotal Research Centers
Midvale, Utah, 84047
Regional Epilepsy Center Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center
New York, New York, 10021
Child Neurology Center of Northwest Florida
Pensacola, Florida, 32504
Bronislav Shafran, M.D., P.C.
Phoenix, Arizona, 85003
Xenoscience
Phoenix, Arizona, 85013
Certified Clinical Research
Roseville, California, 95661
Texas Association of Pediatric Neurology
San Antonio, Texas, 78258
Pharmaceutical Research Organization
South Ogden, Utah, 84403
Dedicated Clinical Research, Inc.
Sun City, Arizona, 85351
Pediatric Diagnostic Center
Ventura, California, 93003
About this study
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
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.
Read the 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.
- Conditions
- Epilepsies, Partial
- Being tested
- Vagus Nerve Stimulation Therapy
- Keywords
- Vagus Nerve Stimulation Therapy, Epilepsies, Partial, Seizures, Antiepileptic Drugs, Refractory Partial Seizures
- Medical subject headings
- Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation TherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
*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 outcomes (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carol C Base, RN, MS, Study director, Cyberonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215215
- Sponsor's protocol ID
- E-20
- Status last verified
- Feb 2006
- First submitted
- 16 Sep 2005
- Last updated
- 22 Feb 2006
- Results posted
- No
Publications
Schachter SC. Vagus nerve stimulation therapy summary: five years after FDA approval. Neurology. 2002 Sep 24;59(6 Suppl 4):S15-20. doi: 10.1212/wnl.59.6_suppl_4.s15.
PubMed 12270963Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology. 2002 Sep 24;59(6 Suppl 4):S26-30. doi: 10.1212/wnl.59.6_suppl_4.s26.
PubMed 12270965Fisher RS, Handforth A. Reassessment: vagus nerve stimulation for epilepsy [RETIRED]: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 1999 Sep 11;53(4):666-9. doi: 10.1212/wnl.53.4.666. No abstract available.
PubMed 10489023Heck 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. doi: 10.1212/wnl.59.6_suppl_4.s31.
PubMed 12270966
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00215215
- Acronym / sponsor ID
- E-20
- Conditions
- Epilepsies, Partial
- Keywords
- Vagus Nerve Stimulation Therapy, Epilepsies, Partial, Seizures, Antiepileptic Drugs, Refractory Partial Seizures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 360 participants
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Nov 2007
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve Stimulation Therapy | Device | – |
Primary outcome
*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.
5 secondary outcomes
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
- Background: PubMed 12270963Schachter SC. Vagus nerve stimulation therapy summary: five years after FDA approval. Neurology. 2002 Sep 24;59(6 Suppl 4):S15-20. doi: 10.1212/wnl.59.6_suppl_4.s15.
- Background: PubMed 12270965Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology. 2002 Sep 24;59(6 Suppl 4):S26-30. doi: 10.1212/wnl.59.6_suppl_4.s26.
- Background: PubMed 10489023Fisher RS, Handforth A. Reassessment: vagus nerve stimulation for epilepsy [RETIRED]: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 1999 Sep 11;53(4):666-9. doi: 10.1212/wnl.53.4.666. No abstract available.
- Background: PubMed 12270966Heck 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. doi: 10.1212/wnl.59.6_suppl_4.s31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol C Base, RN, MS study director
Cyberonics, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vagus Nerve Stimulation Therapy in people with Epilepsies, Partial, run by Cyberonics, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
*Quality of Life in Epilepsy Questionnaire (QOLIE). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00215215, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2006.