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ML-004 · 2 trials · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| ML-004 (IR)/(ER) tablet | EXPERIMENTAL | 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). |
| ML-004 Placebo | PLACEBO_COMPARATOR | Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets). |
| Name | Type | Description |
|---|---|---|
| ML-004 (IR)/(ER) tablet | DRUG | Participants will receive ML-004 once daily. |
| ML-004 Placebo | DRUG | Participants will receive matching placebo once daily. |
Inclusion Criteria: * Has completed Study ML-004-002 within the past 90 days * Age 12 years to 46 years at screening * Has a designated care/study partner who can reliably report on symptoms * Has a diagnosis of Autism Spectrum Disorder (ASD) * Has a body mass index (BMI) ≥18 kg/m² * Psychoactive m...
ML-004 is an investigational small molecule being developed for Autism Spectrum Disorder (ASD). It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied in adolescents and adults with ASD.
ML-004 is being developed by MapLight Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol MPLT. MapLight is conducting clinical trials to evaluate the safety and efficacy of ML-004 in patients with Autism Spectrum Disorder.
ML-004 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in two Phase 2 trials for Autism Spectrum Disorder, one of which has been completed and one that is active but not recruiting.
ML-004 has been studied in two clinical trials. The first, NCT05081245, was a Phase 2 study in adolescents and adults with Autism Spectrum Disorder, which has been completed with 168 participants. The second, NCT05889273, is an open-label extension study with 120 participants, currently active but not recruiting. Both trials were conducted in the United States, Australia, and Canada.
Yes, ML-004 is also known as ML-004 (IR)/(ER) tablet. The drug is being developed in immediate-release and extended-release tablet formulations. This alternative name may be used in clinical trial documentation and other references to the drug.