NCT07459647 A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
| NCT ID | NCT07459647 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | MapLight Therapeutics |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2026-03-31 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
MapLight Therapeutics
STUDY DIRECTOR
MapLight Therapeutics
Frequently Asked Questions
Who can join the NCT07459647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07459647 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07459647 currently recruiting?
Yes, NCT07459647 is actively recruiting participants. Contact the research team at ML-007C-MA-SCZ@maplightrx.com for enrollment information.
Where is the NCT07459647 trial being conducted?
This trial is being conducted at Lemon Grove, United States, Miami Lakes, United States, Chicago, United States, Staten Island, United States and 1 additional location.
Who is sponsoring the NCT07459647 clinical trial?
NCT07459647 is sponsored by MapLight Therapeutics. The principal investigator is MapLight Therapeutics at MapLight Therapeutics. The trial plans to enroll 500 participants.
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