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NCT05889273

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

Active, Not Recruiting
PHASE2Ages 12–46InterventionalTreatment
MapLight Therapeutics
~120 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:ML-004 (IR)/(ER) tablet

At a glance

Recruiting sites
0 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of occurrence of treatment-emergent adverse events (TEAEs).
Measured over Baseline up to Day 362

Conditions

Autism Spectrum Disorder

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Autism Spectrum Disorder

NCT05889273

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abba Medical Group

    Miami, Floridano site contact published

  • APG Research, LLC

    Orlando, Floridano site contact published

  • BioBehavioral Research of Austin

    Austin, Texasno site contact published

  • Brain and Mind Centre

    Camperdown, New South Wales, Australiano site contact published

  • Cortica

    San Rafael, Californiano site contact published

  • Cortica Healthcare

    Glendale, Californiano site contact published

  • Family Psychiatry of The Woodlands

    The Woodlands, Texasno site contact published

  • Harmonex Neuroscience Research

    Dothan, Alabamano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Has completed Study ML-004-002 within the past 90 days
Age 12 years to 46 years 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 kg/m²
Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening
Must be able to swallow study medication

Exclusion

Has Rett syndrome or Child Disintegrative Disorder
History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
Has a clinical history of uncontrolled or severe hypertension
If female, is pregnant or lactating

What this trial measures

  • Frequency of occurrence of treatment-emergent adverse events (TEAEs).Baseline up to Day 362