Long-term ML-007C-MA treatment for adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 52-week open-label, Phase 2 extension and de novo study testing the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with DSM-5 schizophrenia. Participants either roll over from the antecedent ML-007C-MA-211 study or join a de novo cohort and receive ML-007C-MA with regular clinic visits for monitoring and outcome assessments. Key enrollment requirements include the ability to consent, outpatient stability, and availability of a reliable informant, while recent non-schizophrenia psychiatric disorders are excluded. As an open-label design there is no placebo control and data will focus on adverse events, symptom measures, and functional indicators over one year.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Clinical Site
  Rogers, Arkansas, United States Recruiting
• Clinical Site
  Bellflower, California, United States Recruiting
• Clinical Site
  Cerritos, California, United States Recruiting
• Clinical Site
  Culver City, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Contact Center
• Email: ML-007C-MA-SCZ@maplightrx.com
• Phone: +1 650 839 4385

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

• XEP527 in stable schizophrenia: safety and how it behaves in the body

  This small, early-stage study tests the safety and how XEP527 behaves in people with stable schizophrenia who are on a single antipsychotic.

  Recruiting Phase 1 Novartis · Bentonville, Arkansas · NCT07908680

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder

  This study looks at how patients with schizophrenia or bipolar disorder feel and stay safe when treated with quetiapine alone or with other antipsychotics.

  Recruiting Bosnalijek D.D · Sarajevo · NCT07858565

• Neuronavigated rTMS for treatment-resistant auditory hallucinations

  We are testing whether personalized neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations in adults who don’t respond to medication.

  Recruiting Psychiatric University Hospital, Zurich · Zurich · NCT07856368

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.