A Phase 2 interventional study of ML-004 (IR)/(ER) tablet in Autism Spectrum Disorder, sponsored by MapLight Therapeutics. Active, not recruiting at 21 sites in 3 countries. Open to participants aged 12 Years to 46 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by MapLight Therapeutics · Phase 2, Interventional, and Treatment
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →MapLight Therapeutics is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets).
Drug: ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
Frequency of occurrence of treatment-emergent adverse events (TEAEs).
Time frame: Baseline up to Day 362
Frequency of occurrence of Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 362
Frequency of occurrence of TEAEs leading to discontinuation.
Time frame: Baseline up to Day 362
Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.
Time frame: Baseline up to Day 362
Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale.
Time frame: Baseline up to Day 362
Plan to share: Undecided
Started Jun 2023 (actual). Primary completion is estimated for Nov 2027, 53 months after the start.
Of 44 phase 2 interventional studies under Autistic Disorder, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 62. This study's planned 53 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MapLight Therapeutics