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NCT05889273Active, not recruitingPhase 2

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

An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
22 May 2023
Start date
1 Jun 2023
Primary completion date
30 Nov 2027
Lead sponsor
MapLight Therapeutics
Diseases
Autism
NCT number
NCT05889273

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 1 Jun 2023 to the primary completion date, 30 Nov 2027
  • 21 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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 clinical history of uncontrolled or severe hypertension

Other

  • Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
  • If female, is pregnant or lactating

Who the study is looking for

  • 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

Age in the registry: 12 years to 46 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brain and Mind Centre
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CamperdownAustraliaUnknown status
The Royal Children's Hospital, Murdoch Children's Research Institute
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ParkvilleAustraliaUnknown status
Holland Bloorview Kids Rehabilitation Hospital
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TorontoCanadaUnknown status
BioBehavioral Research of Austin
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AustinUnited StatesUnknown status
NeuroBehavioral Medicine Group
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Bloomfield HillsUnited StatesUnknown status
University of Missouri, Thompson Center for Autism & Neurodevelopment
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ColumbiaUnited StatesUnknown status
Harmonex Neuroscience Research
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DothanUnited StatesUnknown status
Cortica Healthcare
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GlendaleUnited StatesUnknown status
Suburban Research Associates
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MediaUnited StatesUnknown status
Abba Medical Group
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MiamiUnited StatesUnknown status
Yale Child Study Center
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New HavenUnited StatesUnknown status
NRC Research Institute
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OrangeUnited StatesUnknown status
Nathan Kline Institute for Psychiatric Research
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OrangeburgUnited StatesUnknown status
APG Research, LLC
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OrlandoUnited StatesUnknown status
Southwest Autism Research and Resource Center
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PhoenixUnited StatesUnknown status
Road Runner Research, Ltd
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San AntonioUnited StatesUnknown status
Cortica
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San RafaelUnited StatesUnknown status
Richmond Behavioral Associates
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Staten IslandUnited StatesUnknown status
University of South Florida, Psychiatry and Behavioral Neurosciences
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TampaUnited StatesUnknown status
Family Psychiatry of The Woodlands
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The WoodlandsUnited StatesUnknown status
The Children's Research Institute
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.