ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
← catalyst calendarSponsored by MapLight Therapeutics (industry) · MPLT — their whole pipeline →.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
168actual
Sites
29
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 | 2022-09-13 | actual | When the study began enrolling |
| Primary completion | 2026-03-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-17 | actual | The whole study's end, after follow-up |
| First posted | 2021-10-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-19 | 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
Interventions
- Drug: ML-004 (IR)/(ER) tablet
- Drug: ML-004 Placebo
Primary outcome
what the primary-completion date above is the date OFChange from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score
measured Baseline up to Day 110
Permalink · MPLT's whole pipeline · Catalyst calendar · Every registered study · What changed