A Randomized, Double-blind, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)

The primary objective of this study is to evaluate the effectiveness and safety of ML-004-002, a new investigational medication, compared with placebo in improving social communication in autistic individuals.

Study Length

Disorder/Condition

Inclusion Criteria

• 12-17 years old
• Diagnosis of autism spectrum disorder (ASD)

Study Description (brief)

The primary objective of this study is to evaluate the effectiveness and safety of ML-004-002, a new investigational medication, compared with placebo in improving social communication in autistic individuals.

Study Contact

Lucia Tu at [email protected] or (845) 398-6620

Exclusion Criteria

• Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs)
• History of migraines

Study Location