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).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05889273

Enrollment

120

Registered

2023-06-05

Start date

2023-06-01

Completion date

2027-12-01

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

ASD, Autism, Autism Spectrum Disorder, Social Communication

Brief 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.

Interventions

DRUGML-004 (IR)/(ER) tablet

Participants will receive ML-004 once daily.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multi-center, open-label study

Eligibility

Sex/Gender

ALL

Age

12 Years to 46 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Frequency of occurrence of Serious Adverse Events (SAEs)	Baseline up to Day 362
Frequency of occurrence of TEAEs leading to discontinuation.	Baseline up to Day 362
Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.	Baseline up to Day 362
Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale.	Baseline up to Day 362

Countries

Australia, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026