NCT05081245Phase 2Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-03-10Actual

Enrollment · participants168Actual

Source updated2026-05-19Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-05-19 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~150 participants (planned)~~

+ After

168 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Oct 2026~~

+ After

10 Mar 2026

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

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Posted 2025-12-04 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Autism Spectrum Disorder

Treatments or interventions studied

ML-004 (IR)/(ER) tabletDrug
ML-004 PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score; description: 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.; timeFrame: Baseline up to Day 110

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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