ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
← catalyst calendarNCT05889273 · readout ≤ 467 d
Sponsored by MapLight Therapeutics (industry) · MPLT — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
120estimated
Sites
21
Countries
Australia, Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-01 | actual | When the study began enrolling |
| Primary completion | Nov 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-06-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Autism Spectrum Disorder
Intervention
- Drug: ML-004 (IR)/(ER) tablet
Primary outcome
what the primary-completion date above is the date OFFrequency of occurrence of treatment-emergent adverse events (TEAEs).
measured Baseline up to Day 362
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