for people ages 12-45 (full criteria)
at San Francisco, California and other locations
study started
completion around



ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.

Official Title

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).


Autism Spectrum Disorder, ASD, Autism, Social Communication, Autistic Disorder, Pervasive Child Development Disorders, ML-004 (IR)/(ER) tablet


You can join if…

Open to people ages 12-45

  • 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

You CAN'T join if...

  • 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 lactating


  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Southwest Autism Research & Resource Center, Clinical Research accepting new patients
    Phoenix Arizona 85006 United States


accepting new patients
Start Date
Completion Date
MapLight Therapeutics
Phase 2 Autism Research Study
Study Type
Expecting 150 study participants
Last Updated