Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05889273

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders

Age range

12 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brain and Mind Centre, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 to screening
  • Must be able to swallow study medication

Exclusion criteria

  • 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

Treatment and study plan

ML-004 (IR)/(ER) tablet

Drug

Participants will receive ML-004 once daily.

Primary outcomes

  1. Frequency of occurrence of treatment-emergent adverse events (TEAEs).

    Time frame: Baseline up to Day 362

Secondary outcomes

  1. Frequency of occurrence of Serious Adverse Events (SAEs)

    Time frame: Baseline up to Day 362

  2. Frequency of occurrence of TEAEs leading to discontinuation.

    Time frame: Baseline up to Day 362

  3. Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.

    Time frame: Baseline up to Day 362

  4. Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale.

    Time frame: Baseline up to Day 362

Sponsors and collaborators

Lead sponsor

MapLight Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.