StudyFinder
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
RECRUITING
12 years to 45 years old
Inclusion Criteria:
* Age 12 to 45 at screening
* Has a designated care/study partner who can reliably report on symptoms
* Has a diagnosis of Autism Spectrum Disorder (ASD)
* Has a body mass index (BMI) 18 through 34 kg/m², inclusive
* Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
* Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
* Must be able to swallow study medication
Exclusion Criteria:
* Has Rett syndrome or Child Disintegrative Disorder
* Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
* History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
* Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
* If female, is pregnant or lactatingDRUG: ML-004 (IR)/(ER) tablet, DRUG: ML-004 Placebo
Autism Spectrum Disorder
ASD, Autism, Autism Spectrum Disorder, Social Communication
Clinical Trials Contact Center - ML-004-002@Maplightrx.com
PHASE2
NCT05081245