A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

NCT05081245 Phase 2 ACTIVE_NOT_RECRUITING

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.

Details

Lead sponsor	MapLight Therapeutics
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	150
Start date	2022-09-13
Completion	2026-11

Conditions

• Autism Spectrum Disorder

Interventions

• ML-004 (IR)/(ER) tablet
• ML-004 Placebo

Primary outcomes

• Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score — Baseline up to Day 110
  Change from baseline in the ABI-Social Communication Domain Score will be reported. The ABI is a 62-item questionnaire for reporting the behaviors of subjects (ages: 3 years-adulthood) diagnosed with ASD. The tool is suitable for completion by parents or care/study partners of people with ASD. Each item assesses either quality (from not at all to without help) or frequency (never to very often) of a particular behavior. The Social Communication domain score is the sum of the scores in the social communication domain divided by the number of items in the domain.

Countries

United States, Australia, Canada