Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children aged 6 to under 16 years old at the time of signing the consent form (and still under 16 after the 12-week treatment period)
• Children of any gender
• Children who have been diagnosed with Autism Spectrum Disorder (ASD) according to standard diagnostic guidelines (DSM-5), with the diagnosis confirmed through a specific structured assessment tool
• Children who score 36 or higher on a standard autism rating scale called the CARS 2-ST
• Children whose overall illness severity is rated at 4 or above on a standard clinical scale (CGI-S), indicating at least a moderate level of severity
• Families who understand the trial and are willing to take part, with the parent or legal guardian signing the consent form; children aged 8 and older are also asked to sign where they are able to do so
• Girls who could potentially become pregnant must agree to either abstain from sexual activity or use reliable contraception throughout the trial and for 3 months after the last dose

Who may not be able to join:

• Children who weigh less than 20 kg or more than 70 kg, or who have a very high BMI of 35 or above
• Women or girls who are pregnant or breastfeeding
• Children who have a serious mental health condition such as schizophrenia, bipolar disorder, or major depression, or who show significant anxiety, agitation, depression, suicidal thinking, risk of self-harm, or serious aggressive or impulsive behaviour
• Children who have had an epileptic seizure in the 3 months before screening, or who have a history of severe neurological disease or serious head injury
• Children with other mental health conditions that, in the investigator's judgement, could affect the trial results
• Children with unstable physical or neurological health conditions that could put them at risk or interfere with how the trial is assessed
• Children whose current educational, behavioural, or other support programmes have not been stable before the trial starts and cannot remain consistent throughout
• Children who are unable to stop, or may need to continue, certain medications or treatments during the trial — including most antipsychotic medications, medications used for ASD or ADHD, brain-boosting (nootropic) drugs, or gut microbiome supplements (confirm with trial site for the specific list)
• Children who have had certain brain stimulation or specialised therapies (such as transcranial magnetic stimulation, brain biofeedback, auditory integration training, or acupuncture) within 2 months before joining, or who may need such treatments during the trial
• Children whose heart (ECG) test or blood test results fall outside acceptable ranges, including abnormal heart rhythm readings, low platelet counts, low haemoglobin, low white blood cell counts, abnormal liver or kidney markers, or any other results the investigator considers clinically significant
• Children who have taken part in another clinical trial (drug or non-drug) within the last month
• Children who are expected to need planned (elective) surgery during the trial
• Children whose parents or guardians are unable to understand or complete the rating scale assessments required by the trial
• Children who have a known allergy or sensitivity to edaravone or any of the ingredients in the study tablet (Soluplus, sodium bisulphite, microcrystalline cellulose, magnesium stearate, or polyvinylpolypyrrolidone)
• Children who the investigator considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.