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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MapLight Therapeutics

Criteria

Inclusion Criteria:

• Has completed Study ML-004-002 within the past 90 days

• Age 12 years to 45 years at screening

• Has a designated care/study partner who can reliably report on symptoms

• Has a diagnosis of Autism Spectrum Disorder (ASD)

• 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