An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders

NCT06772324 | Not Yet Recruiting

• 1 other identifier: PKUH6PSCN001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of low-dose buprenorphine in patients with ASD by using standard ASD symptom assessment methods (e.g., SRS-2 and ABC) as well as AI-assisted analyses utilizing exploratory gaze patterns in conjunction with fMRI and electroencephalogram measurements to assess changes in brain functional status.

Conditions

Autism Spectrum Disorder

Keywords

low-dose Buprenorphine patch; autism spectrum disorders; Buprenorphine

Outcome Measures

Primary Outcomes (2)

• Social Responsiveness Scale (SRS)

  It is a screening tool for the diagnosis and assessment of autism in children aged 4-18 years that recognizes the presence of ASD-related social impairments and quantifies their severity. It identifies ASD-related social impairments and quantifies their severity. The scale consists of 65 questions categorized as Social Self-Consciousness, Social Cognition, Social Communication, and Social Self-Expression. The scale consists of 65 questions divided into five dimensions: social awareness, social cognition, social communication, social motivation, and autistic behavior. There are a total of 65 questions, with a minimum score of 1 and a maximum score of 4 for each question, with a total score range of 65-260. The higher the score, the more significant the condition.

  screening period, Day 1, Day 29, Day 57.

• Autism Behavior Checklist （ABC）

  It is a behavioral assessment tool for children with autism and is primarily used to assess the outcome of patients with mental retardation and autism. The scale consists of 58 items divided into 5 factors: emotional lability/self-injurious aggression (15 items), social withdrawal/stagnation (16 items), stereotypic behavior (7 items), hyperactivity (16 items), and inappropriate speech (4 items). There are a total of 58 questions, each with a minimum score of 0 and a maximum score of 3, with a total score range of 0-174. The higher the score, the more significant the condition.

  Day 1, Day 29, Day 57.

Secondary Outcomes (5)

• Clinical Global Impression (CGI)

  screening period, Day 1, Day 29, Day 57.

• Treatment Emergent Symptom Scale (TESS)

  Day8, Day 29, Day 57.

• Patient Global Impression (PGI)

  Day 1, Day 29, Day 57.

• Eye Tracking Test

  screening period, Day 1, Day8, Day 29, Day 57.

• functional magnetic resonance imaging (fMRI)

  screening period, Day 57.

Study Arms (3)

Very-low dose group

EXPERIMENTAL

Dosing will begin on Day 1, and the buprenorphine transdermal patch will be changed every 7 days, i.e., Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, and Day 57. Of these, Day 15, Day 22, Day 36, Day 43, and Day 50 will require subjects and their guardians to self-replace the patch at home. Day 1, Day 8, Day 29, and Day 57 will receive medication in the hospital. Day1 0 mg patch; all subjects receiving their medication in-hospital after completing all tests assessed at baseline; Day8, Day29 one-ninth of a 5mg patch and replaced with a 0mg patch before returning home from the test; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests; Day57 one-ninth of a 5-mg patch; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests and will be allowed to go home only after removing the used buprenorphine transdermal patch at the end of the assessment;

Drug: NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group

Lower dose group

EXPERIMENTAL

Dosing will begin on Day 1, and the buprenorphine transdermal patch will be changed every 7 days, i.e., Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, and Day 57. Of these, Day 15, Day 22, Day 36, Day 43, and Day 50 will require subjects and their guardians to self-replace the patch at home. Day 1, 8, 29, and 57 will receive medication in the hospital. Day1 one-ninth of a 5 mg patch; all subjects receiving their medication in-hospital after completing all tests assessed at baseline; Day8, Day29 one-ninth of a 5mg patch and replaced with one-ninth of a new 5mg patch before returning home from the test; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests; Day57 one-ninth of a 5-mg patch; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests and will be allowed to go home only after removing the used buprenorphine transdermal patch at the end of the assessment;

Drug: NORSPAN Buprenorphine Transdermal Patchs for Lower dose group

Higher dose group

EXPERIMENTAL

Dosing will begin on Day 1, and the buprenorphine transdermal patch will be changed every 7 days, i.e., Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, and Day 57. Of these, Day 15, Day 22, Day 36, Day 43, and Day 50 will require subjects and their guardians to self-replace the patch at home. Day 1, 8, 29, and 57 will receive medication in the hospital. Day1 one-third of a 5 mg patch; all subjects receiving their medication in-hospital after completing all tests assessed at baseline; Day8, Day29 one-third of a 5mg patch wil be replaced with one-third of a new 5mg patch before returning home from the test; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests; Day57 one-third of a 5-mg patch; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests and will be allowed to go home only after removing the used buprenorphine transdermal patch at the end of the assessment;

Drug: NORSPAN Buprenorphine Transdermal Patchs for higher dose group

Interventions

NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group DRUG

Very-low dose group will receive medication on arrival before completing the relevant assessment tests; the very-low dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch and replaced with a 0mg patch before returning home from the examination.

Very-low dose group

NORSPAN Buprenorphine Transdermal Patchs for Lower dose group DRUG

The lower dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch.

Lower dose group

NORSPAN Buprenorphine Transdermal Patchs for higher dose group DRUG

The higher dose group will be administered 1/3 of a 5mg buprenorphine transdermal patch.

Higher dose group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Sex: male/female;
• Age:6-18 years at the time of randomization;
• Clinical diagnosis in accordance with the DSM-5 diagnosis of ASD;
• Diagnosis of ASD using the K-SADS-PL-C DSM-5 and CARS;
• A severity score of ≥ 4 on the CGI scale;
• Subjects must be able to participate and deemed suitable for participation in the study, at the investigator's discretion, and be able to follow the study evaluation schedule;
• The parent or guardian agrees to accompany the subject to all clinical visits and to provide information about the subject's behavior and symptoms, and must agree to supervise the subject's compliance with protocol-specified procedures and the use of study drug doses;
• The parent or guardian is willing and able to give written informed consent in accordance with local requirements. When the subject is capable of making the decision to consent to participation in the study, the subject is likewise willing and able to provide written informed consent in accordance with local requirements.

You may not qualify if:

• Neurologic/Psychiatric Disorders
• Concurrent comorbidity with any other mental disorder (other than ADHD) as diagnosed by the K-SADS-PL-C DSM-5;
• Neurologic disorders or prior head trauma resulting in coma;
• Unstable or uncontrollable clinically significant psychiatric and/or neurological disorders that may interfere with safety or efficacy outcome;
• Unstable or uncontrolled irritability in the judgment of the investigator;
• Any suicide attempts in the opinion of the investigator at the time of screening that he/she is at risk for suicidal behavior or in his/her medical history;
• A history of seizures within the past 6 months;
• A history of alcohol or other substance abuse/dependence.
• Cardiovascular Disease
• Current cardiovascular disease not effectively controlled in the opinion of the investigator;
• Clinically significant abnormalities (e.g., twice consecutive measurements) as confirmed by ECG at screening, including, but not limited to: QTc: ≥450 milliseconds, absence of predominant sinus rhythm, and second or third degree a-v block.
• Diseases of other organ systems
• Accompanying other diseases or conditions (pulmonary, gastrointestinal, hepatic, renal, metabolic, immune system, or obesity) that may interfere or whose treatment may interfere with the conduct of the study; or where, in the opinion of the Investigator, discontinuation of the Prohibited Substance may pose an unacceptable risk to the subject.
• Evidence of gastrointestinal bleeding, e.g., active gastric ulcer;
• History of coagulopathy, bleeding disorders or blood disorders;

Sponsors & Collaborators

• Peking University Sixth Hospital: lead
• Ping An-Shionogi Co., Ltd.: collaborator

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Qingjiu Cao

CONTACT

+8613141418469; caoqingjiu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization and Masking will be performed via a non-blinded data management team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Model Details: This was a randomized, three-arm, parallel, double-masked study in male/female subjects with ASD with a treatment duration of 56 days. No crossing will be implemented.

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 13, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CN (1)