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
1 other identifier
interventional
300
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Jun 2025
Shorter than P25 for phase_2 schizophrenia
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedStudy Start
First participant enrolled
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
March 9, 2026
July 1, 2025
1.1 years
June 18, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change From Baseline to End of Treatment in CGI-S score
Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder positive factor score
Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder negative factor score
Baseline and End of Treatment (5 weeks)
Study Arms (3)
ML-007C-MA QD
EXPERIMENTALML-007C-MA BID
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
- 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.
- At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S.
- Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements.
You may not qualify if:
- 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.
- 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.
- Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline.
- Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
- Participant is at an elevated risk of suicidal behavior.
- 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.
- 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).
- 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.
- Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Clinical Site
Little Rock, Arkansas, 72211, United States
Clinical Site
Bellflower, California, 90706, United States
Clinical Site
Culver City, California, 90230, United States
Clinical Site
Garden Grove, California, 92845, United States
Clinical Site
Lemon Grove, California, 91945, United States
Clinical Site
Los Angeles, California, 90015, United States
Clinical Site
Montclair, California, 91763, United States
Clinical Site
Orange, California, 92868, United States
Clinical Site
Riverside, California, 92506, United States
Clinical Site
San Diego, California, 92123, United States
Clinical Site
Santee, California, 92071, United States
Clinical Site
Sherman Oaks, California, 91403, United States
Clinical Site
Torrance, California, 90504, United States
Clinical Site
Hollywood, Florida, 33024, United States
Clinical Site
Miami Lakes, Florida, 33016, United States
Clinical Site
West Palm Beach, Florida, 33407, United States
Clinical Site
Atlanta, Georgia, 30331, United States
Clinical Site
Decatur, Georgia, 30030, United States
Clinical Site
Chicago, Illinois, 60640, United States
Clinical Site
Marlton, New Jersey, 08053, United States
Clinical Site
Staten Island, New York, 10314, United States
Clinical Site
North Canton, Ohio, 44720, United States
Clinical Site
Austin, Texas, 78754, United States
Clinical Site
DeSoto, Texas, 75115, United States
Clinical Site
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MapLight Therapeutics
MapLight Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2025
First Posted
June 26, 2025
Study Start
June 27, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
March 9, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share