Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215215
Status:
TERMINATED
Last Update Posted:
2006-02-22
First Post:
2005-09-16
Brief Title:
Effectiveness Study Comparing Treatment With Drugs or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
Sponsor:
Cyberonics Inc
Organization:
Cyberonics Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None