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

NCT05889273 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-16

No results posted yet for this 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.

Conditions

Interventions

DRUG

ML-004 (IR)/(ER) tablet

Participants will receive ML-004 once daily.

Sponsors & Collaborators

  • MapLight Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
46 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2027-11-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05889273 on ClinicalTrials.gov