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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05889273
• Other study ID #: ML-004-003
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: MapLight Therapeutics
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

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
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	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, 

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

External Links

•   ML-004-002