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

Phase 2Enrolling By InvitationNCT05889273

MapLight Therapeutics120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Autism Spectrum Disorder

Interventions

ML-004 (IR)/(ER) tabletDRUG

Participants will receive ML-004 once daily.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 46 Years

Medical Language ↔ Plain English

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

Locations (21)

Harmonex Neuroscience Research

Dothan, Alabama, United States