ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.

Inclusion Criteria:

• Has completed Study ML-004-002 within the past 90 days
• Age 12 years to 46 years 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 kg/m²
• Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening
• Must be able to swallow study medication

Exclusion Criteria:

• Has Rett syndrome or Child Disintegrative Disorder
• History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
• Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
• Has a clinical history of uncontrolled or severe hypertension
• If female, is pregnant or lactating