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

Description

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.

Conditions

Autism Spectrum Disorder

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Study Overview

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Study Details

Study overview

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.

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).

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

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Dothan

Harmonex Neuroscience Research, Dothan, Alabama, United States, 36303

Phoenix

Southwest Autism Research & Resource Center, Clinical Research, Phoenix, Arizona, United States, 85006

Glendale

Cortica Healthcare, Glendale, California, United States, 91203

Orange

NRC Research Institute, Orange, California, United States, 92868

Orange

Thompson Autism and Neurodevelopmental Center, Orange, California, United States, 92868

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

New Haven

Yale Child Study Center, New Haven, Connecticut, United States, 06519

Washington

Children's National Health System - The Children's Research Institute (CRI), Washington, District of Columbia, United States, 20010

Orlando

APG Research, LLC, Orlando, Florida, United States, 32803

Tampa

University of South Florida Psychiatry and Behavioral Neurosciences, Tampa, Florida, United States, 33613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * Has a body mass index (BMI) 18 through 34 kg/m², inclusive
  • * Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
  • * Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
  • * Must be able to swallow study medication
  • * 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 ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
  • * If female, is pregnant or lactating

Ages Eligible for Study

12 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MapLight Therapeutics,

Study Record Dates

2025-04-30