A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient 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

ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis.

The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: ML-007C-MA QD; Drug: ML-007C-MA BID

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Clinical Site
  • California
    • Bellflower, California, United States, 90706
      • Clinical Site
    • Culver City, California, United States, 90230
      • Clinical Site
    • Garden Grove, California, United States, 92845
      • Clinical Site
    • Lemon Grove, California, United States, 91945
      • Clinical Site
    • Los Angeles, California, United States, 90015
      • Clinical Site
    • Montclair, California, United States, 91763
      • Clinical Site
    • Orange, California, United States, 92868
      • Clinical Site
    • Riverside, California, United States, 92506
      • Clinical Site
    • San Diego, California, United States, 92123
      • Clinical Site
    • Sherman Oaks, California, United States, 91403
      • Clinical Site
    • Torrance, California, United States, 90504
      • Clinical Site
  • Florida
    • Hollywood, Florida, United States, 33024
      • Clinical Site
    • Miami Lakes, Florida, United States, 33016
      • Clinical Site
    • West Palm Beach, Florida, United States, 33407
      • Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Clinical Site
    • Decatur, Georgia, United States, 30030
      • Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Clinical Site
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Clinical Site
  • New York
    • Staten Island, New York, United States, 10314
      • Clinical Site
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Clinical Site
  • Texas
    • Austin, Texas, United States, 78754
      • Clinical Site
    • DeSoto, Texas, United States, 75115
      • Clinical Site
    • Richardson, Texas, United States, 75080
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matched Placebo
Experimental: ML-007C-MA QD	Drug: ML-007C-MA QD; ML-007C-MA dosed as 330/6 mg QD
Experimental: ML-007C-MA BID	Drug: ML-007C-MA BID; ML-007C-MA dosed as 210/3 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score	The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.	Baseline and End of Treatment (5 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to End of Treatment in CGI-S score	The CGI-S is a clinician-rated assessment of the severity of a participant's current illness on a 7-point scale, where a higher score is associated with greater severity. Values range from 1 (not ill at all) to 7 (among the most extremely ill).	Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder positive factor score	The Positive Marder Factor score is derived from the PANSS and consists of the sum of 4 positive symptom items (P), one negative symptom item (N) and 3 general symptom items (G) (P1. Delusions; P3. Hallucinations; P5. Grandiosity; P6. Suspiciousness and persecution; N7. Stereotyped thinking; G1. Somatic concern; G9. Unusual thought content; G12. Lack of judgment and insight).	Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder negative factor score	The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative symptom items (N) and 2 general symptom items (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.	Baseline and End of Treatment (5 weeks)

Collaborators and Investigators

• Sponsor: MapLight Therapeutics
• Investigators: Study Director: MapLight Therapeutics, MapLight Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Nervous System Diseases; Central Nervous System Diseases; Mental Disorders; Psychotic Disorders; Brain Diseases; Muscarinic Antagonists; Cholinergic Agents; Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders; Muscarinic Agonists
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: ML-007C-MA-211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No