Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT03664232
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Autism Spectrum Disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) (minimum score of 8 \[autism spectrum\])
* Otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Have a composite score on Kaufman Brief Intelligence Test, Second Edition (KBIT-2) of at least 60
* Must live with a parent or primary caregiver or, if not, during each week he/she must either (A) spend at least 3 hours a day for at least 4 days or, (B) spend the weekend with a parent or primary caregiver
* Any pharmacologic, diet, or behavioral intervention for ASD must have begun at least 1 month prior to the baseline visit and continue unchanged through the treatment period, or have ended at least 1 month prior to the baseline visit
* Must be able to swallow the study medication whole and self-administer medication if living independently or have a parent or caregiver be able to administer medication
* Must agree to abide by the birth control requirements during the study and for 3 months after the last dose
Exclusion Criteria:
* Current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
* Use of a drug with moderate/strong cytochrome P450 (CYP)3A4 inhibiting or inducing properties at, or prior to, screening that is not discontinued at least within 1 month prior to Day 1
* History of drug or alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (except if related to current treatment)
* Currently taking or has taken within the past month recreational or medically prescribed cannabis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
35 Years
Study:
NCT03664232
Study Brief:
Protocol Section:
NCT03664232