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

An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia

ML-007C-MA-212 is a 52-week open-label study designed to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in participants with schizophrenia who have recently completed an antecedent study (ML-007C-MA-211) or enroll directly (De Novo Cohort).

Key Inclusion Criteria:

1. Must be able and willing to provide informed consent for all required study procedures.
2. 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).
3. May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
4. Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
5. 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.

Key Exclusion Criteria:

1. 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.
2. Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
3. Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
4. Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
5. Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
6. Has an elevated risk of suicidal behavior.
7. Has a known allergy to ML-007C-MA, its active ingredients or their excipients.
8. 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).
9. Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.