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
- Clinical Site · Little Rock, AR 72204More trials in Little Rock
- Clinical Site · Little Rock, AR 72211More trials in Little Rock
- Clinical Site · Rogers, AR 72758More trials in Rogers
CA
- Clinical Site · Bellflower, CA 90706More trials in Bellflower
- Clinical Site · Cerritos, CA 90703More trials in Cerritos
- Clinical Site · Culver City, CA 90230More trials in Culver City
- Clinical Site · Garden Grove, CA 92845More trials in Garden Grove
- Clinical Site · Lemon Grove, CA 91945More trials in Lemon Grove
- Clinical Site · Long Beach, CA 90807More trials in Long Beach
- Clinical Site · Los Angeles, CA 90015More trials in Los Angeles
- Clinical Site · Montclair, CA 91763More trials in Montclair
- Clinical Site · Oceanside, CA 92056More trials in Oceanside
- Clinical Site · Orange, CA 92868More trials in Orange
- Clinical Site · Pico Rivera, CA 94596More trials in Pico Rivera
- Clinical Site · Riverside, CA 92506More trials in Riverside
- Clinical Site · San Diego, CA 92123More trials in San Diego
- Clinical Site · Sherman Oaks, CA 91403More trials in Sherman Oaks
- Clinical Site · Torrance, CA 90504More trials in Torrance
FL
- Clinical Site · Hollywood, FL 33021More trials in Hollywood
- Clinical Site · Hollywood, FL 33024More trials in Hollywood
- Clinical Site · Miami, FL 33135More trials in Miami
- Clinical Site · Miami, FL 33166More trials in Miami
- Clinical Site · Miami Lakes, FL 33016More trials in Miami Lakes
- Clinical Site · West Palm Beach, FL 33407More trials in West Palm Beach
GA
- Clinical Site · Atlanta, GA 30331More trials in Atlanta
- Clinical Site · Decatur, GA 30030More trials in Decatur
IL
- Clinical Site · Chicago, IL 60640More trials in Chicago
MA
- Clinical Site · Boston, MA 02116More trials in Boston
- Clinical Site · Watertown, MA 02472More trials in Watertown
MD
- Clinical Site · Gaithersburg, MD 20877More trials in Gaithersburg
MI
- Clinical Site · Ann Arbor, MI 48105More trials in Ann Arbor
MS
- Clinical Site · Flowood, MS 39232More trials in Flowood
NJ
- Clinical Site · Marlton, NJ 08053More trials in Marlton
NV
- Clinical Site · Las Vegas, NV 89119More trials in Las Vegas
NY
- Clinical Site · Cedarhurst, NY 11516More trials in Cedarhurst
- Clinical Site · New York, NY 10029More trials in New York
- Clinical Site · Staten Island, NY 10314More trials in Staten Island
- Clinical Site · The Bronx, NY 10641More trials in The Bronx
OH
- Clinical Site · North Canton, OH 44720More trials in North Canton
- Clinical Site · West Chester, OH 45069More trials in West Chester
PA
- Clinical Site · Philadelphia, PA 19104More trials in Philadelphia
TX
- Clinical Site · Austin, TX 78754More trials in Austin
- Clinical Site · DeSoto, TX 75115More trials in DeSoto
- Clinical Site · Houston, TX 77081More trials in Houston
- Clinical Site · Richardson, TX 75080More trials in Richardson