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

Last updated: March 19, 2025
Sponsor: MapLight Therapeutics
Overall Status: Active - Enrolling

Phase

2

Condition

Autism Spectrum Disorder (Asd)

Asperger's Disorder

Autism

Treatment

ML-004 (IR)/(ER) tablet

Clinical Study ID

NCT05889273
ML-004-003
  • Ages 12-46
  • All Genders

Study Summary

ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 toscreening

  • Must be able to swallow study medication

Exclusion

Exclusion Criteria:

  • Has Rett syndrome or Child Disintegrative Disorder

  • History of epilepsy without current adequate control, or any seizure in the 6 monthspreceding screening

  • Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk forsuicidal behavior

  • Has a clinical history of uncontrolled or severe hypertension

  • If female, is pregnant or lactating

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: ML-004 (IR)/(ER) tablet
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Brain and Mind Centre

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • The Royal Children's Hospital, Murdoch Children's Research Institute

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario M4G 1R8
    Canada

    Site Not Available

  • Harmonex Neuroscience Research

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Cortica Healthcare

    Glendale, California 91203
    United States

    Site Not Available

  • NRC Research Institute

    Orange, California 92868
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • University of South Florida Psychiatry and Behavioral Neurosciences

    Tampa, Florida 33613
    United States

    Site Not Available

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • University of Missouri, Thompson Center for Autism & Neurodevelopment

    Columbia, Missouri 65211
    United States

    Site Not Available

  • Nathan Kline Institute for Psychiatric Research

    Orangeburg, New York 10962
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10314
    United States

    Site Not Available

  • Ohio State University Nisonger Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Red Oak Psychiatry Associates, PA

    Houston, Texas 77090
    United States

    Site Not Available

  • Road Runner Research, Ltd.

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Cedar Clinical Research

    Draper, Utah 84020
    United States

    Site Not Available

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