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

An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia

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).

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: ML-007C-MA

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Contact Center; Phone Number: +1 650 839 4385; Email: ML-007C-MA-SCZ@maplightrx.com

Study Locations

• United States
  • California
    • Lemon Grove, California, United States, 91945
      • Recruiting
      • Clinical Site
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Recruiting
      • Clinical Site
  • New York
    • Staten Island, New York, United States, 10314
      • Recruiting
      • Clinical Site
  • Texas
    • DeSoto, Texas, United States, 75115
      • Recruiting
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ML-007C-MA	Drug: ML-007C-MA; ML-007C-MA dosed as 210/3 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: MapLight Therapeutics
• Investigators: Study Director: MapLight Therapeutics, MapLight Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; Nervous System Diseases; Central Nervous System Diseases; Mental Disorders; Psychotic Disorders; Brain Diseases; Muscarinic Antagonists; Cholinergic Agents; Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders; Muscarinic Agonists
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: ML-007C-MA-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No