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

NCT07459647 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ML-007C-MA-212
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 42

Brief 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).

Conditions

Schizophrenia

Keywords

Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders; Mental Disorders; Psychotic Disorders; Schizophrenia; Muscarinic Antagonists; Muscarinic Agonists; Cholinergic Agents; Nervous System Diseases; Central Nervous System Diseases; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia

  using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.

  From initial dose through end of treatment (up to 52 weeks)

Study Arms (1)

ML-007C-MA

EXPERIMENTAL

Drug: ML-007C-MA

Interventions

ML-007C-MA DRUG

ML-007C-MA dosed as 210/3 mg BID

ML-007C-MA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able and willing to provide informed consent for all required study procedures.
• 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).
• May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
• Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
• 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.

You may not qualify if:

• 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.
• Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
• Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
• Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
• Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
• Has an elevated risk of suicidal behavior.
• Has a known allergy to ML-007C-MA, its active ingredients or their excipients.
• 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).
• Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.

Sponsors & Collaborators

• MapLight Therapeutics: lead

Study Sites (42)

Clinical Site

Little Rock, Arkansas, 72204, United States

RECRUITING

Clinical Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Clinical Site

Rogers, Arkansas, 72758, United States

RECRUITING

Clinical Site

Bellflower, California, 90706, United States

RECRUITING

Clinical Site

Cerritos, California, 90703, United States

RECRUITING

Clinical Site

Culver City, California, 90230, United States

RECRUITING

Clinical Site

Garden Grove, California, 92845, United States

RECRUITING

Clinical Site

Lemon Grove, California, 91945, United States

RECRUITING

Clinical Site

Long Beach, California, 90807, United States

RECRUITING

Clinical Site

Los Angeles, California, 90015, United States

RECRUITING

Clinical Site

Montclair, California, 91763, United States

RECRUITING

Clinical Site

Oceanside, California, 92056, United States

RECRUITING

Clinical Site

Orange, California, 92868, United States

RECRUITING

Clinical Site

Pico Rivera, California, 94596, United States

RECRUITING

Clinical Site

Riverside, California, 92506, United States

RECRUITING

Clinical Site

San Diego, California, 92123, United States

RECRUITING

Clinical Site

Sherman Oaks, California, 91403, United States

RECRUITING

Clinical Site

Torrance, California, 90504, United States

RECRUITING

Clinical Site

Hollywood, Florida, 33021, United States

RECRUITING

Clinical Site

Hollywood, Florida, 33024, United States

RECRUITING

Clinical Site

Miami, Florida, 33166, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site

West Palm Beach, Florida, 33407, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30331, United States

RECRUITING

Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site

Chicago, Illinois, 60640, United States

RECRUITING

Clinical Site

Gaithersburg, Maryland, 20877, United States

RECRUITING

Clinical Site

Boston, Massachusetts, 02116, United States

RECRUITING

Clinical Site

Watertown, Massachusetts, 02472, United States

RECRUITING

Clinical Site

Ann Arbor, Michigan, 48105, United States

RECRUITING

Clinical Site

Las Vegas, Nevada, 89102, United States

RECRUITING

Clinical Site

Las Vegas, Nevada, 89119, United States

RECRUITING

Clinical Site

Marlton, New Jersey, 08053, United States

RECRUITING

Clinical Site

New York, New York, 10029, United States

RECRUITING

Clinical Site

Staten Island, New York, 10314, United States

RECRUITING

Clinical Site

The Bronx, New York, 10641, United States

RECRUITING

Clinical Site

North Canton, Ohio, 44720, United States

RECRUITING

Clinical Site

West Chester, Ohio, 45069, United States

RECRUITING

Clinical Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Clinical Site

Austin, Texas, 78754, United States

RECRUITING

Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Clinical Site

Richardson, Texas, 75080, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders; Nervous System Diseases; Central Nervous System Diseases; Brain Diseases

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• MapLight Therapeutics

  MapLight Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Contact Center

CONTACT

+1 650 839 4385; ML-007C-MA-SCZ@maplightrx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)