NCT07459647

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
43mo left

Started Mar 2026

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Feb 2030

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

April 22, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 5, 2026

Last Update Submit

April 17, 2026

Conditions

Schizophrenia

Keywords

Schizophrenia Spectrum and Other Psychotic Disorders Mental DisordersMental DisordersPsychotic DisordersSchizophreniaMuscarinic AntagonistsMuscarinic AgonistsCholinergic AgentsNervous System DiseasesCentral Nervous System DiseasesBrain 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-MADRUG

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

ML-007C-MA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinical Site

Lemon Grove, California, 91945, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site

Chicago, Illinois, 60640, United States

RECRUITING

Clinical Site

Staten Island, New York, 10314, United States

RECRUITING

Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaMental DisordersPsychotic DisordersNervous System DiseasesCentral Nervous System DiseasesBrain 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 4385ML-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

April 22, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)