Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD (NCT06757504) | Clinical Trial Compass
RecruitingPhase 2
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
China150 participantsStarted 2025-01-13
Plain-language summary
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.
Who can participate
Age range6 Years – 16 Years
SexALL
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Inclusion criteria
✓. Aged ≥ 6 to \<16 years at the time of signing the ICF (age \<16 years after 12-week treatment), including adolescents aged ≥ 12 to\<16 years at the time of signing the ICF (age \<16 years after 12-week treatment), and children aged ≥ 6 to\<12 years at the time of signing the ICF;
✓. Male or female;
✓. Participants diagnosed with ASD according to the ASD diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Schedule for Affective Disorders and Schizophrenia for School Aged Children Present and Lifetime version (K-SADS-PL), DSM-5 ASD module;
✓. Participants and their legal guardians understand and are willing to participate in this trial, with ICF signed by the legal guardian and participants aged ≥ 8 years; for participants who, at the discretion of the investigator, have cognitive deficits that prevent them from signing the ICF, their legal guardians sign the ICF on behalf of them;
✓. Females of childbearing potential (as defined in Appendix 15.1) agree to remain abstinent or use a reliable method of contraception for the duration of the trial and until 3 months after the last dose of the investigational product.
Exclusion criteria
✕. Weight \<20.0 kg or \>70.0 kg, or BMI ≥35.0 kg/m\^2;
✕. Pregnant or lactating women;
✕
What they're measuring
1
Change from baseline in ABC-SW（Aberrant Behavioral Checklist - Social Withdrawal） scores at Week 12.
Timeframe: At baseline and week 12
2
Incidence and severity of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and TEAEs that lead to treatment discontinuation.
Timeframe: Throughout the trial period
3
Plasma concentrations and population PK profiles of edaravone and its metabolites in adolescent and pediatric ASD participants.
Timeframe: Visit 2 (Day 1): 30 minutes (±5 minutes) and 3 hours (±10 minutes) after the first dose; Visit 8 (Week 12 ±2 Days)or Early withdrawal: before the first dose (0 hour), and 30 minutes (±5 minutes) after the first dose on the day of the visit.
. Presence of a serious mental disorder as assessed by the investigator, e.g., schizophrenia, bipolar disorder, depressive disorder, etc.; the presence of significant anxiety, tension, agitation, fear, depression, or the presence of suicidal risk, significant risk of self-injury, impulsivity, aggression, or behaviors based on the medical history and the routine mental status examination;
✕. History of epileptic seizures within 3 months prior to screening, or presence of a history of severe physical or neurological disease, history of severe head trauma;
✕. Participants with a history or symptoms of other mental illness that, at the discretion of the investigator, may affect the results of the study;
✕. Participants with a history of any unstable physical or neurological condition or currently suffering from a physical or neurological condition that, at the discretion of the investigator, may put them at risk of a significant adverse event or interfere with the assessment of safety and efficacy during the course of the trial;
✕. Pre-existing educational training and/or behavioral treatments fail to be stabilized prior to screening and consistent throughout the trial;
✕. Participants who are unable to discontinue or may use other treatments during the screening period and throughout the trial due to their condition, including: antipsychotic medications (except those that may be used in combination during the trial as specified in the protocol), medications that may have a therapeutic effect on ASD, nootropic drugs, medications for ADHD, intestinal flora modification, and other intestinal flora modification supplementation alternatives;