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Clinical Trials in Canada / NCT05889273
Active, not recruiting Phase 2

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

NCT05889273 · tracked via the Priya Life Science Canada tracker
Sponsor
MapLight Therapeutics
Phase
Phase 2
Started
2023-06-01
Last updated
2026-07-20

Condition(s) studied

Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

ML-004 (IR)/(ER) tablet

ML-004 (IR)/(ER) tablet: Participants will receive ML-004 once daily.

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

Sex
ALL
Min age
12 Years
Max age
46 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Harmonex Neuroscience Research Dothan Alabama
Southwest Autism Research and Resource Center Phoenix Arizona
Cortica Healthcare Glendale California
NRC Research Institute Orange California
Cortica San Rafael California
Yale Child Study Center New Haven Connecticut
The Children's Research Institute Washington D.C. District of Columbia
Abba Medical Group Miami Florida
APG Research, LLC Orlando Florida
University of South Florida Psychiatry and Behavioral Neurosciences Tampa Florida
Neurobehavioral Medicine Group Bloomfield Hills Michigan
University of Missouri, Thompson Center for Autism & Neurodevelopment Columbia Missouri
Nathan Kline Institute for Psychiatric Research Orangeburg New York
Richmond Behavioral Associates Staten Island New York
Suburban Research Associates Media Pennsylvania
BioBehavioral Research of Austin Austin Texas
Road Runner Research, Ltd. San Antonio Texas
Family Psychiatry of The Woodlands The Woodlands Texas
Brain and Mind Centre Camperdown New South Wales
The Royal Children's Hospital, Murdoch Children's Research Institute Parkville Victoria
Holland Bloorview Kids Rehabilitation Hospital Toronto Ontario

More MapLight Therapeutics trials in Canada

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis Recruiting

Other trials for the same condition

Psilocybin for Treatment-Resistant Depression in Autism Active, not recruiting
rTMS for Depression in Young Adults With Autism Recruiting
Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children Recruiting
Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment Recruiting
Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05889273 on ClinicalTrials.gov ↗ ← All trials in Canada