Autism Spectrum DisorderNCT06772324
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
A study testing NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group, NORSPAN Buprenorphine Transdermal Patchs for Lower dose group and NORSPAN Buprenorphine Transdermal Patchs for higher dose group in people with Autism Spectrum Disorder, run by Peking University Sixth Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group, NORSPAN Buprenorphine Transdermal Patchs for Lower dose group and NORSPAN Buprenorphine Transdermal Patchs for higher dose group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Other exclusion criteria
- Marked respiratory depression;
- Acute or severe bronchial asthma;
- Known or suspected paralytic bowel obstruction;
- Allergic to buprenorphine;
- Participation in a drug study within 30 days prior to randomization or within 5 times the half-life of the molecule to be studied, whichever is longer; or drug study; or participation in a study testing a medical device within 30 days prior to randomization, or the device is still in action. active;
- History of blood loss greater than 250 mL within 3 months prior to screening;
- Medications permitted since 4 weeks prior to screening that have NOT been clearified and stable, and medications permitted for the treatment of epilepsy since 3 months prior to screening that have NOT been clearified and stable.
- Usage of a prohibited medication within 2 weeks prior to the screening visit (and ensuring at least 4 weeks of washout time prior to the baseline assessment) or usage of a prohibited medication within 5 times of half-life prior to the randomization (whichever is longer).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Sixth Hospital
Beijing, Beijing Municipality
Qingjiu Cao, 86+13141418469, caoqingjiu@163.com
About this study
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.
Read the detailed description
The study aims to assess the safety and efficacy of buprenorphine in patients with autism spectrum disorders (ASD) in very low, lower, and higher dose groups and to explore the sensitivity and specificity of ophthalmoscopy for evaluating the efficacy of ASD treatment. Combined neuroimaging techniques to examine the effects of buprenorphine on neurologic function in ASD.
In this study, changes in functional brain status will be assessed by using standard ASD symptom assessment methods (e.g., SRS and ABC) as well as algorithms utilizing AI's exploratory gaze patterns in conjunction with functional magnetic resonance and electroencephalography imaging to evaluate changes in the functional brain state of the very low-dose group (5 mg 1/9 at follow-up only), the lower-dose group (5 mg 1/9/week) and the higher-dose group (5 mg 1/3/week) buprenorphine safety and efficacy in patients with ASD. This study will validate the results of previous studies based on humans and rodents and is expected to develop an effective drug for treating the core symptoms of ASD with significant social and economic benefits.
This is a randomized, three-arm, double-blind study in male/female subjects with ASD with a treatment duration of 56 days. Items to be evaluated include efficacy on ASD symptoms, safety, Day57's buprenorphine drug concentration in plasma, and changes in oculomotor, functional magnetic resonance, and electroencephalographic data before and after treatment. The effective dose is estimated based on the results of preclinical studies of buprenorphine in ASD model mice, using a dose of one-third or one-ninth of the available 5-mg buprenorphine transdermal patch.
- Conditions
- Autism Spectrum Disorder
- Being tested
- NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group, NORSPAN Buprenorphine Transdermal Patchs for Lower dose group, NORSPAN Buprenorphine Transdermal Patchs for higher dose group
- Keywords
- low-dose Buprenorphine patch, autism spectrum disorders, Buprenorphine
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NORSPAN Buprenorphine Transdermal Patchs for Very-low dose groupDrug
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.
NORSPAN Buprenorphine Transdermal Patchs for Lower dose groupDrug
The lower dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch.
NORSPAN Buprenorphine Transdermal Patchs for higher dose groupDrug
The higher dose group will be administered 1/3 of a 5mg buprenorphine transdermal patch.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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; Receives: 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; Receives: Drug: NORSPAN Buprenorphine Transdermal Patchs for higher dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1, Day 29, Day 57.
Secondary outcomes (5)
Clinical Global Impression (CGI)
It is an overall rating scale that is applicable to any psychiatric treatment and research subject.
The comprehensive score is based on the two dimensions of efficacy and adverse reactions. The most effective and least adverse reaction score is 1 point, while the least effective and most adverse reaction score is 16 points. The score range is 1-16.
Measured: screening period, Day 1, Day 29, Day 57.
Treatment Emergent Symptom Scale (TESS)
It is a medication safety evaluation tool used by psychiatrists to assess side effects in patients taking psychotropic medications.
There are a total of 29 questions, each with three dimensions: severity, relationship with medication, and treatment. The score range for severity is 0-4, with higher scores indicating greater severity. The score range for the relationship with drugs is 0-4, and the higher the score, the greater the relationship with drugs. The processing range is 0-6, and the higher the score, the greater the degree of processing.
Measured: Day8, Day 29, Day 57.
Patient Global Impression (PGI)
There are two questions in total, namely severity and overall evaluation of efficacy. The score range for severity is 0-4, with higher scores indicating greater severity. The score range for the overall efficacy evaluation is 0-7, with higher scores indicating greater deterioration of the condition.
Measured: Day 1, Day 29, Day 57.
Eye Tracking Test
Subjects will be seated in front of a monitor equipped with eye-tracking equipment. The equipment will be adjusted according to the subject's actual condition before the formal start. After commissioning, a 1-2 minute video will be played and eye movement data will be collected during the video.
The eye movement data will be analyzed by quantifying the ratio of the length of time the patient looks at the face of the person appearing in the video to the length of time he/she looks at the geometric figure, the length of time he/she looks at the eye region of the person, and so on.
Measured: screening period, Day 1, Day8, Day 29, Day 57.
functional magnetic resonance imaging (fMRI)
Includes resting-state fMRI data, DTI data, and ASL data, collected during the screening period and at visit 5, respectively.
Measured: screening period, Day 57.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ping An-Shionogi Co., Ltd.
- Responsible party
- Principal investigator, Qingjiu Cao, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772324
- Sponsor's protocol ID
- PKUH6PSCN001
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06772324
- Acronym / sponsor ID
- PKUH6PSCN001
- Conditions
- Autism Spectrum Disorder
- Keywords
- low-dose Buprenorphine patch, autism spectrum disorders, Buprenorphine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Collaborators
- Ping An-Shionogi Co., Ltd.
- Study start
- Jan 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to assess the safety and efficacy of buprenorphine in patients with autism spectrum disorders (ASD) in very low, lower, and higher dose groups and to explore the sensitivity and specificity of ophthalmoscopy for evaluating the efficacy of ASD treatment. Combined neuroimaging techniques to examine the effects of buprenorphine on neurologic function in ASD.
In this study, changes in functional brain status will be assessed by using standard ASD symptom assessment methods (e.g., SRS and ABC) as well as algorithms utilizing AI's exploratory gaze patterns in conjunction with functional magnetic resonance and electroencephalography imaging to evaluate changes in the functional brain state of the very low-dose group (5 mg 1/9 at follow-up only), the lower-dose group (5 mg 1/9/week) and the higher-dose group (5 mg 1/3/week) buprenorphine safety and efficacy in patients with ASD. This study will validate the results of previous studies based on humans and rodents and is expected to develop an effective drug for treating the core symptoms of ASD with significant social and economic benefits.
This is a randomized, three-arm, double-blind study in male/female subjects with ASD with a treatment duration of 56 days. Items to be evaluated include efficacy on ASD symptoms, safety, Day57's buprenorphine drug concentration in plasma, and changes in oculomotor, functional magnetic resonance, and electroencephalographic data before and after treatment. The effective dose is estimated based on the results of preclinical studies of buprenorphine in ASD model mice, using a dose of one-third or one-ninth of the available 5-mg buprenorphine transdermal patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Very-low dose group | Experimental | Drug: NORSPAN Buprenorphine Transdermal Patchs for Very-low dose groupDosing 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; |
| Lower dose group | Experimental | Drug: NORSPAN Buprenorphine Transdermal Patchs for Lower dose groupDosing 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; |
| Higher dose group | Experimental | Drug: NORSPAN Buprenorphine Transdermal Patchs for higher dose groupDosing 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; |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (24 listed)
- Neurologic/Psychiatric Disorders
- Cardiovascular Disease
- Diseases of other organ systems
- Other exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NORSPAN Buprenorphine Transdermal Patchs for Very-low dose groupVery-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. | Drug | Very-low dose group |
| NORSPAN Buprenorphine Transdermal Patchs for Lower dose groupThe lower dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch. | Drug | Lower dose group |
| NORSPAN Buprenorphine Transdermal Patchs for higher dose groupThe higher dose group will be administered 1/3 of a 5mg buprenorphine transdermal patch. | Drug | Higher dose group |
Primary outcome
Social Responsiveness Scale (SRS)
Time frame: screening period, Day 1, Day 29, Day 57.
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.
Autism Behavior Checklist （ABC）
Time frame: Day 1, Day 29, Day 57.
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.
5 secondary outcomes
Clinical Global Impression (CGI)
Time frame: screening period, Day 1, Day 29, Day 57.
Treatment Emergent Symptom Scale (TESS)
Time frame: Day8, Day 29, Day 57.
Patient Global Impression (PGI)
Time frame: Day 1, Day 29, Day 57.
Eye Tracking Test
Time frame: screening period, Day 1, Day8, Day 29, Day 57.
functional magnetic resonance imaging (fMRI)
Time frame: screening period, Day 57.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group, NORSPAN Buprenorphine Transdermal Patchs for Lower dose group and NORSPAN Buprenorphine Transdermal Patchs for higher dose group in people with Autism Spectrum Disorder, run by Peking University Sixth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingjiu Cao (+8613141418469, caoqingjiu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness Scale (SRS) (time frame: screening period, Day 1, Day 29, Day 57.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.