ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

ML-004-002 is a multi-center, randomized, double-blind, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD

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

Details

• Lead Sponsor: MapLight Therapeutics

Criteria

Inclusion Criteria:

• Age 12 to 45 at screening

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

• Has a diagnosis of Autism Spectrum Disorder (ASD)

• Full scale IQ (or equivalent) ≥70 score

• Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening

• Must be able to swallow study medication

Exclusion Criteria:

• Has Rett syndrome or Child Disintegrative Disorder

• Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening

• History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening

• History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5

• Systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100, or a clinical history of uncontrolled or severe hypertension

• If female, is pregnant or lactating