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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Harmonex Neuroscience Research
  Dothan, Alabama, United States Recruiting
• Southwest Autism Research & Resource Center, Clinical Research
  Phoenix, Arizona, United States Recruiting
• Cortica Healthcare
  Glendale, California, United States Recruiting
• NRC Research Institute
  Orange, California, United States Recruiting
• Thompson Autism and Neurodevelopmental Center
  Orange, California, United States Recruiting
• Cortica
  San Rafael, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Contact Center
• Email: ML-004-002@Maplightrx.com
• Phone: +1 650-839-4388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.