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) [1]
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 [2] 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)