Single-center, Double-blind, Placebo-controlled, Randomized Clinical Trials for Safety and Efficacy Assessment of Symptoms Related to Autism Spectrum Disorder Using NuEyne P01 in Patients With Autism Spectrum Disorder

Nu Eyne Co., Ltd.1 site in 1 country30 target enrollmentNovember 15, 2022

ConditionsAutism Spectrum Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Nu Eyne Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Safety evaluation
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.

Detailed Description

Duration of study period (per participant): Screening period (-28\~0 days), Intervention period (28 days) Patient needs to visit site at least 4 times (V1, V2, V4, V6). V2 can be done with V1. Tele-visit should be done on V3 (day 7), V5 (day 21).

Registry

clinicaltrials.gov

Start Date

November 15, 2022

End Date

August 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nu Eyne Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children over 7 years old and under 12 years old
•Patients diagnosed with autism spectrum disorder
•A person who has a total intelligence index of 70 or higher and has no problems with basic language communication
•A person who agrees not to use any medical device other than this clinical trial medical device during the clinical trial period
•A person who does not take a concurrent drug from screening to the end of the study, or who can maintain the concurrent drug during the clinical trial period without any change or addition
•Voluntary written consent to participate in this clinical trial

Exclusion Criteria

•Those who participated in other clinical trials within 30 days from the screening date
•If it is difficult to understand the contents of treatment due to the limitation of intelligence index or language ability, and if it is difficult to conduct a study
•When there is a risk of clinically significant behavioral problems, emotional control problems, psychiatric symptoms, self-harm, or other harm that can affect the treatment process
•Psychiatric hospitalization history
•A person with acute or chronic medical or mental illness
•A person with a history of seizures
•Serious trauma and surgery within 1 month
•A person who is deemed to have a problem with the adhesion of electrodes due to inflammatory reactions or other dermatological problems on the skin around the forehead to which electrodes of clinical trial medical devices are attached
•If it is need to take sleep medications \[benzodiazepine, melatonin, trazodone\] (\*However, it is participated after having a washout period of at least two weeks.)
•A person who is deemed to have other reasons for prohibition of use of clinical trial medical devices (including heart-related problems, seizures, metal or electronic devices implanted in the head, people with unknown pain, pacemaker transplant, etc.)

Outcomes

Primary Outcomes

Safety evaluation

Time Frame: baseline, 4 weeks

Occurrence of adverse events caused by the investigational device, including psychiatric abnormality, skin abnormality at the contact site, headache, sleepiness, trigeminal nerve abnormality, etc. is checked.