Actively Recruiting
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
Led by Shanghai Auzone Biological Technology Co., Ltd. · Updated on 2025-05-14
150
Participants Needed
5
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, randomized, double-blind, multiple dose levels, parallal group, placebo-controlled study, to evaluate the safety, PK profiles and preliminary efficacy of TTYP01 tablets in adolescents and children with ASD.
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6 to under 16 years at the time of consent
- Male or female
- Diagnosed with Autism Spectrum Disorder (ASD) confirmed by DSM-5 and K-SADS-PL
- Child Autism Rating Scale 2-ST (CARS 2-ST) raw score of 36 or higher
- Clinical Global Impression-Severity (CGI-S) score of 4 or higher
- Participant and legal guardian understand the trial and have signed informed consent (guardian signs if participant has cognitive deficits)
- Females of childbearing potential agree to abstain or use reliable contraception during the trial and for 3 months after last dose
You will not qualify if you...
- Weight under 20.0 kg or over 70.0 kg, or BMI 35.0 kg/m² or higher
- Pregnant or breastfeeding females
- Serious mental disorders such as schizophrenia, bipolar disorder, or major depression
- Significant anxiety, fear, depression, suicidal risk, self-injury risk, impulsivity, or aggression
- Epileptic seizures within 3 months before screening
- History of severe physical or neurological disease or severe head trauma
- Other mental illnesses affecting study results as judged by investigator
- Unstable physical or neurological conditions posing risk or interfering with assessments
- Unstable pre-existing educational or behavioral treatments before screening
- Use of prohibited medications or treatments during screening or trial (e.g., antipsychotics, ADHD medications, nootropics)
- Use of certain therapies (e.g., magnetic stimulation, biofeedback, acupuncture) within 2 months before randomization
- Abnormal ECG or lab results outside site normal ranges affecting safety
- Participation in another clinical trial within 1 month
- Expected elective surgery during the trial
- Parents/guardians unable to complete assessments
- Allergic to edaravone or tablet excipients
- Judged ineligible by investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Peking University Sixth Hospital
Beijing, China
Actively Recruiting
2
The Second Xiangya Hospital of Central South University
Changsha, China
Not Yet Recruiting
3
West China Hospital of Sichuan University
Chengdu, China
Not Yet Recruiting
4
Nanjing Brain Hospital, The Affiliated Brain Hospital of Nanjing Medical University
Nanjing, China
Not Yet Recruiting
5
Tianjin Mental Health Center
Tianjin, China
Not Yet Recruiting
Research Team
X
Xiaolong Hou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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