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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05889273
Other study ID # ML-004-003
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date June 1, 2023
Est. completion date June 2026

Study information

Verified date May 2024
Source MapLight Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 120
Est. completion date June 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years to 46 Years
Eligibility 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia Brain and Mind Centre Camperdown New South Wales
Australia The Royal Children's Hospital, Murdoch Children's Research Institute Parkville Victoria
Canada Holland Bloorview Kids Rehabilitation Hospital Toronto Ontario
United States University of Missouri, Thompson Center for Autism & Neurodevelopment Columbia Missouri
United States Harmonex Neuroscience Research Dothan Alabama
United States Cedar Clinical Research Draper Utah
United States Red Oak Psychiatry Associates, PA Houston Texas
United States Suburban Research Associates Media Pennsylvania
United States APG Research, LLC Orlando Florida
United States Southwest Autism Research and Resource Center Phoenix Arizona
United States Road Runner Research, Ltd. San Antonio Texas
United States Richmond Behavioral Associates Staten Island New York
United States University of South Florida Psychiatry and Behavioral Neurosciences Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
MapLight Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

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