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Recruiting Phase 2

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

NCT07459647 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-03-31
Last updated
2026-10-15

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

ML-007C-MA →

ML-007C-MA: ML-007C-MA dosed as 210/3 mg BID

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia — From initial dose through end of treatment (up to 52 weeks)
    using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.

Trial sites (45)

FacilityCityRegionStatus
Clinical Site Little Rock Arkansas Recruiting
Clinical Site Little Rock Arkansas Recruiting
Clinical Site Rogers Arkansas Recruiting
Clinical Site Bellflower California Recruiting
Clinical Site Cerritos California Recruiting
Clinical Site Culver City California Recruiting
Clinical Site Garden Grove California Recruiting
Clinical Site Lemon Grove California Recruiting
Clinical Site Long Beach California Recruiting
Clinical Site Los Angeles California Recruiting
Clinical Site Montclair California Recruiting
Clinical Site Oceanside California Recruiting
Clinical Site Orange California Recruiting
Clinical Site Pico Rivera California Recruiting
Clinical Site Riverside California Recruiting
Clinical Site San Diego California Recruiting
Clinical Site Sherman Oaks California Recruiting
Clinical Site Torrance California Recruiting
Clinical Site Hollywood Florida Recruiting
Clinical Site Hollywood Florida Recruiting
Clinical Site Miami Florida Recruiting
Clinical Site Miami Florida Recruiting
Clinical Site Miami Lakes Florida Recruiting
Clinical Site West Palm Beach Florida Recruiting
Clinical Site Atlanta Georgia Recruiting
Clinical Site Decatur Georgia Recruiting
Clinical Site Chicago Illinois Recruiting
Clinical Site Gaithersburg Maryland Recruiting
Clinical Site Boston Massachusetts Recruiting
Clinical Site Watertown Massachusetts Recruiting
Clinical Site Ann Arbor Michigan Recruiting
Clinical Site Flowood Mississippi Recruiting
Clinical Site Las Vegas Nevada Recruiting
Clinical Site Marlton New Jersey Recruiting
Clinical Site Cedarhurst New York Recruiting
Clinical Site New York New York Recruiting
Clinical Site Staten Island New York Recruiting
Clinical Site The Bronx New York Recruiting
Clinical Site North Canton Ohio Recruiting
Clinical Site West Chester Ohio Recruiting

+ 5 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07459647 on ClinicalTrials.gov ↗ ← All trials in the USA