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

Approximately 6 months

Disorder/Condition

Autism Spectrum Disorder

Inclusion Criteria

  • 18-45 years old
  • Diagnosis of autism spectrum disorder (ASD)

Study Title (brief)

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)

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 Lucia.Tu@NKI.rfmh.org 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

Nathan Kline Institute (Orangeburg, NY)
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