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ML-007C-MA for hospitalized adults with schizophrenia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Orally Administered ML-007C-MA in Inpatient Adult Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis

Phase 2 Interventional MapLight Therapeutics · NCT07038876

This trial will test whether taking ML-007C-MA once or twice daily helps adults aged 18–64 who are hospitalized for a sudden worsening of schizophrenia compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorMapLight Therapeutics Industry-sponsored
Locations25 sites (Little Rock, Arkansas and 24 other locations)
Trial IDNCT07038876 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, double-blind, placebo-controlled inpatient study testing oral ML-007C-MA given once daily or twice daily in adults 18–64 experiencing an acute exacerbation of schizophrenia. Participants must meet DSM-5 criteria for schizophrenia and have at least moderate symptoms by PANSS and CGI-S, and they must be willing to remain in an inpatient setting for the study. The primary outcome is change in PANSS Total Score versus placebo, with safety and tolerability also monitored. Eligible subjects are randomized to ML-007C-MA QD, ML-007C-MA BID, or placebo under blinded conditions.

Who should consider this trial

Good fit: Adults aged 18–64 with a DSM-5 diagnosis of schizophrenia who are currently hospitalized (or need hospitalization) for an acute exacerbation with at least moderate symptoms and who can remain inpatient for the study duration.

Not a fit: People who are not hospitalized for an acute exacerbation, who have another primary DSM-5 disorder within the past year, who cannot remain inpatient, or who fall outside the age range are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, ML-007C-MA could shorten or reduce acute psychotic symptoms in hospitalized patients and add a new oral treatment option for acute schizophrenia exacerbations.

How similar studies have performed: Other drugs targeting muscarinic receptors (for example xanomeline-based approaches) have shown promising results in recent trials, but ML-007C-MA itself is a distinct investigational compound being tested in this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Participant 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).
2. Participant may benefit from hospitalization or is currently hospitalized due to an acute exacerbation of schizophrenia symptoms, with exacerbation onset within 2 months of Screening. If the participant is already hospitalized for acute exacerbation of schizophrenia at Screening, they must have been inpatient for less than 2 weeks at the start of Screening.
3. At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S.
4. Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements.

Key Exclusion Criteria:

1. Participant has any DSM-5 disorder, other than schizophrenia, within 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
2. Participant has any psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before Screening and/or current involuntary hospitalization or incarceration.
3. Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline.
4. Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
5. Participant is at an elevated risk of suicidal behavior.
6. Participant has a known or likely allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients or has a known or likely severe allergic reaction (eg, anaphylactic reaction, angioedema) to any drug that could pose a risk to the participant in this study.
7. Participant 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 International Neuropsychiatric Interview).
8. Participation in a clinical research study involving the administration of an investigational or marketed drug, biological product, or device within 90 days of Baseline, or concomitant active participation in an investigational study involving no drug, biological product, or device. Participants who have previously participated in a study with ML-007 may not participate.
9. Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment.

Where this trial is running

Little Rock, Arkansas and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders Mental DisordersMental DisordersPsychotic DisordersMuscarinic AntagonistsMuscarinic AgonistsCholinergic AgentsBrain Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.