A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia

Prior treatment

• Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
• Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
• Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
• Has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening).

Other illness

• Has a known allergy to ML-007C-MA, its active ingredients or their excipients.

Lab values

• Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.

Other

• Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
• Has an elevated risk of suicidal behavior.
• Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.

• Must be able and willing to provide informed consent for all required study procedures.
• Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5).
• May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
• Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
• Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \>1 year.