Long-term ML-007C-MA treatment for 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
This 52-week open-label study will try ML-007C-MA as a long-term medication for adults with schizophrenia who finished an earlier ML-007C-MA study or enroll directly.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | MapLight Therapeutics Industry-sponsored |
| Locations | 5 sites (Lemon Grove, California and 4 other locations) |
| Trial ID | NCT07459647 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with DSM-5 schizophrenia who can provide informed consent, are appropriate for outpatient care, and either completed the prior ML-007C-MA-211 study or can enroll directly with a reliable informant are ideal candidates.
Not a fit: People whose current symptoms are primarily due to another recent DSM-5 disorder, who require inpatient care, or who cannot tolerate muscarinic-targeted medications are unlikely to benefit.
Why it matters
Potential benefit: If successful, ML-007C-MA could offer a new long-term treatment option with sustained symptom control and acceptable tolerability for some people with schizophrenia.
How similar studies have performed: Muscarinic-targeted approaches are relatively novel; early-phase studies of related agents have shown some promise for psychosis symptoms but larger, confirmatory trials remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lemon Grove, California and 4 other locations
- Clinical Site — Lemon Grove, California, United States (Recruiting)
- Clinical Site — Miami Lakes, Florida, United States (Recruiting)
- Clinical Site — Chicago, Illinois, United States (Recruiting)
- Clinical Site — Staten Island, New York, United States (Recruiting)
- Clinical Site — DeSoto, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Contact Center
- Email: ML-007C-MA-SCZ@maplightrx.com
- Phone: +1 650 839 4385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.