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NCT02632149 Clinical Trial

Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome

Lennox-Gastaut Syndrome Clinical Trial

Official title:
The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02632149
Other study ID # PINS-017
Secondary ID
Status Recruiting
Phase Phase 0
First received December 13, 2015
Last updated October 7, 2016
Start date October 2016

Study information
Verified date October 2016
Source Beijing Pins Medical Co., Ltd
Contact Fumin Ph D Jia
Phone +86 010-59361265
Email pins_medical@163.con
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.

Recruitment information / eligibility
Status Recruiting
Enrollment 31
Est. completion date
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 14 Years
Eligibility Inclusion Criteria:

1. Age 3-14 year

2. Lennox - Gastaut syndrome diagnostic standard

3. Regular drug treatment is invalid

4. Antiepileptic drug stability in recent 3 months

5. Good health except epilepsy

6. Patients or his(her) familyscould understand this method and sign the informed consent

7. Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions

2. Had epileptic foci excision surgery or corpus callosum

3. The vagus nerve lesion and damage

4. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma, mental disease,peptic ulcer,diabetes Type 1,bad health etc, and other surgical contraindication

5. Participated in other clinical drug test subjects within three months

6. The researchers think that is not suitable for participants'

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• PINS Vagus Nerve Stimulator

Locations
Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong
China JiNing First People's Hospital JiNing Shandong
China Linyi People's Hospital Linyi Shandong
China The Affiliated Hospital of Qingdao University QingDao Shandong
China Yantai Yuhuangding Hospital Yantai Shandong

Sponsors (5)
Lead Sponsor Collaborator
Beijing Pins Medical Co., Ltd Linyi People's Hospital, Qilu Hospital, Qingdao University, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in seizure frequency from baseline to the seizure count evaluation period 6 month 6 month of stimulation No
Secondary Changes in seizure frequency from baseline to the seizure count evaluation period 1,3,6,months of stimulation No
Secondary Change from Baseline in the Engel and McHugh description At 1,3,6 months No
Secondary Overall WISC Score in Patients from Baseline Mean change from baseline WISC Overall Score at 1,3,6months No
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Completed NCT01146951 - A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) Phase 3
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Withdrawn NCT02318537 - Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome Phase 3
Completed NCT01160770 - Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome Phase 3
Completed NCT03650452 - A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies Phase 2
Withdrawn NCT01370486 - Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects Phase 4
Completed NCT02731300 - Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study Phase 4
Completed NCT02224690 - A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults Phase 3