Trials / Terminated
TerminatedNCT00522418
Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients
An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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 pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vagal Nerve Simulation (VNS) Therapy | VNS Therapy + Best Medical Practice including anti-epileptic drugs |
| DRUG | Best Medical Practive | Best Medical Practice including anti-Epileptic Drugs |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2007-08-29
- Last updated
- 2015-01-26
- Results posted
- 2010-05-17
Locations
48 sites across 10 countries: Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00522418. Inclusion in this directory is not an endorsement.