Clinical trial NCT05889273: ML-004 Open-Label Extension Study in Adults and Adolescents with Autism Spectrum Disorders (ASD)
Official title: An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD).
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: ASD
Autism
Autism Spectrum Disorder
Social Communication
Lead sponsor: MapLight Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center, open-label study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Frequency of occurrence of treatment-emergent adverse events (TEAEs).
timeFrame: Baseline up to Day 362
Secondary outcomes:
measure: Frequency of occurrence of Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 362
measure: Frequency of occurrence of TEAEs leading to discontinuation.
timeFrame: Baseline up to Day 362
measure: Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.
timeFrame: Baseline up to Day 362
measure: Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale.
timeFrame: Baseline up to Day 362
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: Glendale
country: United States
facility: Cortica Healthcare
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Orlando
country: United States
facility: APG Research, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida Psychiatry and Behavioral Neurosciences
state: Florida
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Columbia
country: United States
facility: University of Missouri, Thompson Center for Autism & Neurodevelopment
state: Missouri
city: Orangeburg
country: United States
facility: Nathan Kline Institute for Psychiatric Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Columbus
country: United States
facility: Ohio State University Nisonger Center
state: Ohio
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Camperdown
country: Australia
facility: Brain and Mind Centre
state: New South Wales
city: Parkville
country: Australia
facility: The Royal Children's Hospital, Murdoch Children's Research Institute
state: Victoria
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
References: