Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
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
Sponsor: Cyberonics, Inc.
Terminated
This trial was terminated. No reason was provided.
A PHASE4 clinical study on Epilepsies, Partial, this trial is terminated or withdrawn. The trial is conducted by Cyberonics, Inc. and has accumulated 5 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Terminated PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE4
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE4
-
Jan 2017 — Jun 2018 [monthly]
Terminated PHASE4
First recorded
Feb 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Cyberonics, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .