# Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures

> **NCT01118455** · PHASE4 · TERMINATED · sponsor: **Cyberonics, Inc.** · enrollment: 134 (actual)

## Conditions studied

- Epilepsy

## Interventions

- **DEVICE:** Vagus Nerve Stimulation (VNS) Therapy
- **DRUG:** Anti-Epileptic Drug (AED)

## Key facts

- **NCT ID:** NCT01118455
- **Lead sponsor:** Cyberonics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2004-10
- **Primary completion:** 2009-12
- **Final completion:** 2010-01
- **Target enrollment:** 134 (ACTUAL)
- **Why stopped:** Insufficient enrollment
- **Last updated:** 2014-06-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01118455

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01118455, "Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01118455. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*