Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

ClinicalTrials.gov 112 recruiting now official registry

Autism Spectrum Disorder clinical trials

112 of 225 indexed Autism Spectrum Disorder trials are currently recruiting.

225 US clinical trials · 112 currently recruiting

Autism Spectrum Disorder is the subject of 225 registered US clinical trials on ClinicalTrials.gov, 112 of them currently open to new participants. 4 are in Phase 3-4 (later-stage) and 49 in Phase 1-2 (earlier-stage). The most active sponsor is Stanford University, running 19 of these trials.

The research picture

Autism Spectrum Disorder has 225 registered US clinical trials, 112 of them open to new participants right now, about 50% of the total.

112
recruiting participants now
50%
of trials open to enrollment
4
in Phase 3–4 (later-stage)
19
top sponsor: Stanford University
Phase 112Phase 237Phase 32Phase 42

Active & Recent Trials

225 total, page 1 of 5

RECRUITING 1,500 participants

International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder

Stalicla

NCT05590715

RECRUITING 1,100 participants

Developing Brain, Impulsivity and Compulsivity

National Institute of Mental Health (NIMH)

NCT04631042

RECRUITING 1,000 participants

Longitudinal Study of Neurogenetic Disorders

Columbia University

NCT03492060

RECRUITING 1,000 participants

Patterns of Neurodevelopmental Disorders

Richard Frye

NCT06213090

RECRUITING NA 720 participants

Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool

Vanderbilt University Medical Center

NCT05047224

RECRUITING NA 672 participants

Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services

San Diego State University

NCT06651086

RECRUITING NA 540 participants

Improving Social Communication in Individuals With ASD Using AI

Stanford University

NCT05987774

RECRUITING Phase 4 500 participants

AWARE: Management of ADHD in Autism Spectrum Disorder

Daniel Coury

NCT05916339

RECRUITING Phase 3 500 participants

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Intra-Cellular Therapies

NCT06229210

RECRUITING 500 participants

Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

Southwest Autism Research & Resource Center

NCT04322734

RECRUITING NA 470 participants

Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

University of Pittsburgh

NCT06158581

RECRUITING NA 440 participants

Improving the Part C Early Intervention Service Delivery System for Children with ASD

University of Washington

NCT05114538

RECRUITING NA 376 participants

Physical Activity and Community EmPOWERment Project

University of North Carolina, Chapel Hill

NCT06740162

RECRUITING NA 350 participants

School-based Paraeducator Education for Engagement at Recess

University of Washington

NCT06559267

RECRUITING 350 participants

SenseToKnow Autism Screening Device Validation Study

Duke University

NCT05874466

RECRUITING NA 300 participants

Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

University of North Carolina, Chapel Hill

NCT06060860

RECRUITING NA 300 participants

Early Diagnostic Response Model (EDRM)

Emory University

NCT05419895

RECRUITING NA 297 participants

COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD

Ball State University

NCT06309160

RECRUITING NA 280 participants

Autism Research Project With Non-Invasive Near-Infrared Light Stimulation

University of Texas at Austin

NCT06203938

RECRUITING NA 240 participants

Evaluating Additive Effects of Including Canines in Regulating Together

Children's Hospital Medical Center, Cincinnati

NCT05803343

RECRUITING NA 224 participants

Improving Academic and Social Functioning in Middle-Schoolers With Autism

Children's Hospital Medical Center, Cincinnati

NCT06705907

RECRUITING NA 200 participants

A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students

University of Colorado, Denver

NCT05863520

RECRUITING NA 200 participants

Cerebellar Stimulation and Cognitive Control

Krystal Parker, PhD

NCT03217110

RECRUITING Phase 4 196 participants

The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine

Gagan Joshi

NCT06853665

RECRUITING NA 192 participants

STRW-T Intervention for Autistic Adolescents in 11th and 12th Grade

Children's Hospital Medical Center, Cincinnati

NCT06552286

RECRUITING NA 188 participants

Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

Hugo W. Moser Research Institute at Kennedy Krieger

NCT05176808

RECRUITING Phase 2 184 participants

Optimizing Outcomes for Young Autistic Children

Northwestern University

NCT05926687

RECRUITING NA 180 participants

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

University of Missouri-Columbia

NCT04545606

RECRUITING NA 180 participants

Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders

Children's Hospital Medical Center, Cincinnati

NCT06227780

RECRUITING NA 160 participants

Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention (RUBI)

University of Washington

NCT06508515

RECRUITING NA 150 participants

Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

University of California, San Diego

NCT05741840

RECRUITING Phase 2 144 participants

Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial

Stanford University

NCT05664789

RECRUITING NA 139 participants

Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Baylor College of Medicine

NCT06537128

RECRUITING NA 132 participants

Peer Interventions for Preschoolers With Autism

University of Kansas

NCT05799599

RECRUITING NA 120 participants

Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Stanford University

NCT04899544

RECRUITING NA 106 participants

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

National Institute of Mental Health (NIMH)

NCT04798274

RECRUITING NA 104 participants

How Simplified Language Affects Comprehension and Learning in Young Autistic Children

Michigan State University

NCT05707923

RECRUITING 100 participants

Sleep and Central Auditory Processing Disorder in Autism Spectrum Disorder

Loma Linda University

NCT06059352

RECRUITING Phase 1 100 participants

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Adia Med of Winter Park

NCT07304440

RECRUITING Phase 3 100 participants

Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

Vanda Pharmaceuticals

NCT05361707

RECRUITING NA 100 participants

Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism

University of Kansas

NCT05125003

RECRUITING Phase 2 100 participants

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

Montefiore Medical Center

NCT03202303

RECRUITING NA 100 participants

Word Learning From Parentese in Autistic Children

The University of Texas at Dallas

NCT06649916

RECRUITING Phase 2 96 participants

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

Elizabeth Austen Lawson

NCT05754073

RECRUITING Phase 2 90 participants

Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD

Stanford University

NCT05268796

RECRUITING NA 90 participants

Neural Basis of Social Cognition Deficits

Loma Linda University

NCT05185128

RECRUITING NA 80 participants

Cerebellum and Autism: Regional Specialization for Social and Executive Functions

American University

NCT05396352

RECRUITING Phase 2 80 participants

Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium

Southwest Autism Research & Resource Center

NCT04060017

RECRUITING NA 80 participants

STEPS Implementation Trial

University of Alabama, Tuscaloo

NCT05695885

RECRUITING 80 participants

SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism

American Federation of Medical Synergetics

NCT03222375

Page 1 of 5 Next →

Phase Distribution

PhaseTrial count
Phase 1 12
Phase 2 37
Phase 3 2
Phase 4 2

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Autism Spectrum Disorder Trial Landscape

225 indexed Autism Spectrum Disorder studies · 112 recruiting (50%).

Phase mix: 4 late (III/IV) vs 49 early (I/II).

Top sponsor: Stanford University (19 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Autism Spectrum Disorder?

PlainTrial tracks 225 US clinical trials for Autism Spectrum Disorder, of which 112 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Autism Spectrum Disorder?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.