DrugEvidence

Diseases / Autism Spectrum Disorder

Autism Spectrum Disorder

Disease

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent differences in social communication and interaction, alongside restricted or repetitive patterns of behavior, interests, or activities.

Trials
1690
Recruiting
285
Completed
882
With results
189

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownNo longer availableTotal
Early Phase 1 2292 15
Phase 1 231302314 46
Phase 1/2 3211111 19
Phase 2 22611077131018 148
Phase 2/3 215112 12
Phase 3 2322611 35
Phase 4 311621 23
Not applicable 1896717445672916143 1072
Unknown 6017613145642661 320

Trials started per year

2021
25
2022
140
2023
181
2024
174
2025
139
2026
131
2027
5
2028
1

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Autism Spectrum Disorder 1546191481235231072320 1690
Autistic Disorder 415959416928587 488
Attention Deficit Disorder with Hyperactivity 113145025 85
Anxiety Disorders 292486 67
Neurodevelopmental Disorders 134020 64
Child Development Disorders, Pervasive 118312915 58
Intellectual Disability 113323 58
Asperger Syndrome 119222213 50
Communication 113381 44
Developmental Disabilities 132513 42

Most active sponsors

#SponsorTrialsPhase 3
1National Taiwan University Hospital420
2Stanford University404
3Massachusetts General Hospital375
4Riphah International University280
5Yale University240
6Holland Bloorview Kids Rehabilitation Hospital221
7Istituto per la Ricerca e l'Innovazione Biomedica220
8Children's Hospital Medical Center, Cincinnati210
9Chinese University of Hong Kong180
10Emory University181

Most studied interventions

#InterventionTrials
1Therapeutics34
2Oxytocin18
3Transcranial Magnetic Stimulation18
4Cognitive Behavioral Therapy17
5Behavior Therapy13
6Exercise12
7Transcranial Direct Current Stimulation12
8Control Groups11
9Fecal Microbiota Transplantation9
10Leucovorin9

Evidence

Results reported
21.4%189 of 882 completed
Published
9.6%85 of 882 completed
Primary endpoint met
36.1%78 of 216 analyses
Median months to report
14

Documents disclosed

Protocol available
197
Statistical analysis plan
177
PubMed citations
401

Trial profile

Median enrollment
59
Median duration
26.1months
Countries
66
Study sites
2288

Who is enrolled

Adults
714
Children
1431
Older adults
295
Healthy volunteers
475

Median enrollment by phase

Early Phase 1
22
Phase 1
25
Phase 1/2
20
Phase 2
50
Phase 2/3
90
Phase 3
98
Phase 4
40
Not applicable
52
Unknown
100

Where trials run

United States
761
France
105
Italy
85
China
82
Canada
69
Taiwan
60
Turkey (Türkiye)
54
United Kingdom
49
Pakistan
46
Hong Kong
45

Busiest cities

#CityCountryTrials
1BostonUnited States66
2NashvilleUnited States48
3PhoenixUnited States45
4New YorkUnited States44
5TorontoCanada43
6CincinnatiUnited States41
7PhiladelphiaUnited States40
8StanfordUnited States40
9Los AngelesUnited States39
10SeattleUnited States39

Terminations

Terminated
60
Withdrawn
35
Suspended
4
Stopped for recruitment
0.8%14 of 1690 trials

Stated reasons

Other / unclear
41
COVID-19
20
Recruitment
14
Funding
11
Safety
5
Regulatory
4
Business decision
2
Lack of efficacy
2

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT04031469 Suspended Suspended Administrative 2030-12-10
NCT04100863 Withdrawn Withdrawn Company focus shifted 2030-06-30
NCT06259201 Withdrawn Withdrawn Investigator decided to terminate the study - no participant enrolled. 2027-12-31
NCT07047976 Withdrawn Withdrawn Study terminated prior to full implementation due to logistical and resource-related considerations. Study procedures and feasibility are currently being re-evaluated, and a revised protocol is under development for future implementation. 2026-07-01
NCT06794476 Withdrawn Withdrawn Investigator left Vanderbilt University Medical Center and trial had not yet enrolled any participants. 2026-03-18
NCT04909710 Withdrawn Withdrawn we are suspending this study until we have continued funding. 2026-02-28
NCT05456139 Terminated Terminated NIMH determined that the grant was not feasible due to lack of sufficient participant recruitment and negotiated a bilateral termination of this grant on 04/01/2025. Recruitment was halted and an orderly phase-out plan was approved and implemented. 2026-01-31
NCT03553875 Terminated Terminated requested by the IRB 2025-11-25
NCT05098392 Terminated Terminated Difficulty in recruiting required participants. 2025-09-07
NCT03432065 Withdrawn Withdrawn This study was withdrawn due to competing research interests and slow recruitment. 2025-08-31

Trial records