RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 52-week study tests how safe ML-007C-MA is, how well people tolerate it, and how well it works over time. It is for adults with schizophrenia who recently finished study ML-007C-MA-211 or join directly. Everyone knows which study drug they are taking.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can and will give informed consent, meaning you understand and agree to all required study steps.
  • Have schizophrenia as your main diagnosis, confirmed through a mental health interview.
  • The study doctor thinks long-term medicine for schizophrenia may help you.
  • The study doctor thinks you can receive care without staying in a hospital and have a stable place to live.
  • Have a reliable person who can answer questions about you. Study staff may do this if they have had regular contact with you for more than a year.

Who can't join

  • Had a mental health condition other than schizophrenia in the past 12 months that is the main cause of your current symptoms or trouble with daily life.
  • Are stopping medicine for schizophrenia that works well and does not cause troublesome side effects just to join this study.
  • Received a treatment not allowed during screening, unless it is stopped before the study's starting visit.
  • Have a serious or unstable medical condition, or important abnormal findings on a physical exam, heart tracing (ECG), or safety lab tests at screening or the starting visit.
  • Have a higher risk of suicidal behavior.
  • Have a known allergy to ML-007C-MA or any of its ingredients.
  • Had a moderate or severe substance use disorder—problems from alcohol or drug use—in the past 12 months, except for tobacco or caffeine.
  • The study doctor thinks you have a higher risk of violent or destructive behavior based on your history.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (45)

AR

CA

FL

GA

IL

MA

MD

MI

MS

NJ

NV

NY

OH

PA

TX