A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ML-007C-MA.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia
Overview
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).
Interventions
- Drug ML-007C-MA
ML-007C-MA dosed as 210/3 mg BID
Primary outcome measures
- To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia [Time frame: From initial dose through end of treatment (up to 52 weeks)]
Eligibility criteria
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.
- 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).
- Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Clinical Site — Lemon Grove
- Clinical Site — Miami Lakes
- Clinical Site — Chicago
- Clinical Site — Staten Island
- Clinical Site — DeSoto
Identifiers
NCT: NCT07459647 · ML-007C-MA-212