A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia
NCT ID: NCT07038876
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2025-06-27
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ML-007C-MA 330/6 mg QD
ML-007C-MA QD
ML-007C-MA dosed as 330/6 mg QD
ML-007C-MA 210/3 mg BID
ML-007C-MA BID
ML-007C-MA dosed as 210/3 mg BID
Placebo
Placebo
Matched Placebo
Interventions
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Placebo
Matched Placebo
ML-007C-MA BID
ML-007C-MA dosed as 210/3 mg BID
ML-007C-MA QD
ML-007C-MA dosed as 330/6 mg QD
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
No
Sponsors
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MapLight Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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MapLight Therapeutics
Role: STUDY_DIRECTOR
MapLight Therapeutics
Locations
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Clinical Site
Little Rock, Arkansas, United States
Clinical Site
Bellflower, California, United States
Clinical Site
Culver City, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Montclair, California, United States
Clinical Site
Orange, California, United States
Clinical Site
Riverside, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Santee, California, United States
Clinical Site
Sherman Oaks, California, United States
Clinical Site
Torrance, California, United States
Clinical Site
Hollywood, Florida, United States
Clinical Site
Miami Lakes, Florida, United States
Clinical Site
West Palm Beach, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Marlton, New Jersey, United States
Clinical Site
Staten Island, New York, United States
Clinical Site
North Canton, Ohio, United States
Clinical Site
Austin, Texas, United States
Clinical Site
DeSoto, Texas, United States
Clinical Site
Richardson, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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ML-007C-MA-211
Identifier Type: -
Identifier Source: org_study_id
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