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Evaluating ML-004 for improving social communication in individuals with Autism Spectrum Disorder

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).

Phase 2 Interventional MapLight Therapeutics · NCT05081245

This study is testing if a new treatment called ML-004 can help improve social communication skills in teens and adults with Autism Spectrum Disorder.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages12 Years to 45 Years
SexAll
SponsorMapLight Therapeutics Industry-sponsored
Locations39 sites (Dothan, Alabama and 38 other locations)
Trial IDNCT05081245 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to assess the efficacy of ML-004 in enhancing social communication skills among adolescents and adults diagnosed with Autism Spectrum Disorder (ASD). Approximately 150 participants aged 12 to 45 will be enrolled, with a designated care partner to report on symptoms. The study will compare the effects of ML-004 against a placebo over a specified period, focusing on measurable improvements in social communication deficits associated with ASD.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents and adults aged 12 to 45 with a diagnosis of Autism Spectrum Disorder and stable psychoactive medications.

Not a fit: Patients with Rett syndrome, Child Disintegrative Disorder, or uncontrolled epilepsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve social communication abilities in individuals with Autism Spectrum Disorder.

How similar studies have performed: While there have been studies targeting social communication in ASD, the specific approach with ML-004 is novel and has not been extensively tested in this population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Dothan, Alabama and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Autism Spectrum DisorderASDAutismSocial Communication
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.