ACTIVE_NOT_RECRUITING

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

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Conditions

Autism Spectrum DisorderASDAutismSocial Communication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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).

Quick Facts

Study Start:2022-09-13
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05081245

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.

Ages Eligible for Study:12 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 12 to 45 at screening
  2. * Has a designated care/study partner who can reliably report on symptoms
  3. * Has a diagnosis of Autism Spectrum Disorder (ASD)
  4. * Has a body mass index (BMI) 18 through 34 kg/m², inclusive
  5. * Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
  6. * Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
  7. * Must be able to swallow study medication
  1. * Has Rett syndrome or Child Disintegrative Disorder
  2. * 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
  3. * History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
  4. * History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
  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
  6. * If female, is pregnant or lactating

Contacts and Locations

Study Locations (Sites)

Harmonex Neuroscience Research
Dothan, Alabama, 36303
United States
Southwest Autism Research & Resource Center, Clinical Research
Phoenix, Arizona, 85006
United States
Cortica Healthcare
Glendale, California, 91203
United States
NRC Research Institute
Orange, California, 92868
United States
Cortica
San Rafael, California, 94903
United States
Yale Child Study Center
New Haven, Connecticut, 06519
United States
Children's National Health System - The Children's Research Institute (CRI)
Washington D.C., District of Columbia, 20010
United States
Abba Medical Group
Miami, Florida, 33176
United States
APG Research, LLC
Orlando, Florida, 32803
United States
University of South Florida Psychiatry and Behavioral Neurosciences
Tampa, Florida, 33613
United States
Massachusetts General hospital
Boston, Massachusetts, 02114
United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
United States
University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
Columbia, Missouri, 65211
United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
United States
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, 10962
United States
Richmond Behavioral Associates
Staten Island, New York, 10314
United States
Center for Autism and the Developing Brain, New York State Psychiatric Institute
White Plains, New York, 10605
United States
Ohio State University Nisonger Center
Columbus, Ohio, 43210
United States
Suburban Research Associates
Media, Pennsylvania, 19063
United States
BioBehavioral Research of Austin
Austin, Texas, 78759
United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
United States
Road Runner Research, Ltd.
San Antonio, Texas, 78249
United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
United States
Cedar Clinical Research
Draper, Utah, 84020
United States
Virginia Commonwealth University
Richmond, Virginia, 23220
United States

Collaborators and Investigators

Sponsor: MapLight Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-13
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-09-13
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • ASD
  • Autism
  • Autism Spectrum Disorder
  • Social Communication

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder