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NCT07459647PHASE2Recruiting

A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia

MapLight Therapeutics

Start Date

3/31/2026

Completion Date

2/1/2030

Summary

ML-007C-MA-212 is a 52-week open-label study designed to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in participants with schizophrenia who have recently completed an antecedent study (ML-007C-MA-211) or enroll directly (De Novo Cohort).

Eligibility Criteria

Age Range: 18 years to 65 years

Key Inclusion Criteria: 1. Must be able and willing to provide informed consent for all required study procedures. 2. 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). 3. May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator. 4. Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator. 5. Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \>1 year. Key Exclusion Criteria: 1. Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment. 2. Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study. 3. Has received any prohibited therapy within the Screening Period unless discontinued before Baseline. 4. Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline. 5. Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline. 6. Has an elevated risk of suicidal behavior. 7. Has a known allergy to ML-007C-MA, its active ingredients or their excipients. 8. 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 version 7.0.2 at Screening). 9. Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.

Interventions

DRUG

ML-007C-MA

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Conditions

Schizophrenia

Locations

Clinical Site

Little Rock, Arkansas 72204

United States

Clinical Site

Little Rock, Arkansas 72211

United States

Clinical Site

Rogers, Arkansas 72758

United States

Clinical Site

Bellflower, California 90706

United States

Clinical Site

Cerritos, California 90703

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

Long Beach, California 90807

United States

Clinical Site

Los Angeles, California 90015

United States

Clinical Site

Montclair, California 91763

United States

Clinical Site

Oceanside, California 92056

United States

Clinical Site

Orange, California 92868

United States

Clinical Site

Pico Rivera, California 94596

United States

Clinical Site

Riverside, California 92506

United States

Clinical Site

San Diego, California 92123

United States

Clinical Site

Sherman Oaks, California 91403

United States

Clinical Site

Torrance, California 90504

United States

Clinical Site

Hollywood, Florida 33021

United States

Clinical Site

Hollywood, Florida 33024

United States

Clinical Site

Miami, Florida 33166

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

Gaithersburg, Maryland 20877

United States

Clinical Site

Boston, Massachusetts 02116

United States

Clinical Site

Watertown, Massachusetts 02472

United States

Clinical Site

Ann Arbor, Michigan 48105

United States

Clinical Site

Las Vegas, Nevada 89102

United States

Clinical Site

Las Vegas, Nevada 89119

United States

Clinical Site

Marlton, New Jersey 08053

United States

Clinical Site

New York, New York 10029

United States

Clinical Site

Staten Island, New York 10314

United States

Clinical Site

The Bronx, New York 10641

United States

Clinical Site

North Canton, Ohio 44720

United States

Clinical Site

West Chester, Ohio 45069

United States

Clinical Site

Philadelphia, Pennsylvania 19104

United States

Clinical Site

Austin, Texas 78754

United States

Clinical Site

DeSoto, Texas 75115

United States

Clinical Site

Richardson, Texas 75080

United States