RECRUITING

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

Conditions

Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Mental Disorders Psychotic Disorders Muscarinic Antagonists Muscarinic Agonists Cholinergic Agents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-27

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07038876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Clinical Trials Contact Center

CONTACT

+1 650 839 4385

ML-007C-MA-SCZ@maplightrx.com

Principal Investigator

MapLight Therapeutics

STUDY_DIRECTOR

MapLight Therapeutics

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: MapLight Therapeutics

MapLight Therapeutics, STUDY_DIRECTOR, MapLight Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27

Study Completion Date2027-01

Study Record Updates

Study Start Date2025-06-27

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders
Mental Disorders
Psychotic Disorders
Schizophrenia
Muscarinic Antagonists
Muscarinic Agonists
Cholinergic Agents

Additional Relevant MeSH Terms

Schizophrenia