A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia (NCT07459647) | Clinical Trial Compass
RecruitingPhase 2
A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
United States500 participantsStarted 2026-03-31
Plain-language summary
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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia
Timeframe: From initial dose through end of treatment (up to 52 weeks)
. Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
. Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
. Has an elevated risk of suicidal behavior.
. Has a known allergy to ML-007C-MA, its active ingredients or their excipients.
. 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).