Actively Recruiting
An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia
Led by MapLight Therapeutics · Updated on 2026-04-22
500
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a 52-week open-label study to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with schizophrenia. This study includes participants who have recently completed a prior study (ML-007C-MA-211) as well as new participants enrolling directly. The goal is to better understand how ML-007C-MA performs over an extended period in managing schizophrenia symptoms. Participants will receive ML-007C-MA dosed as 210/3 mg twice daily throughout the 52-week treatment period. The study is designed as an open-label trial, meaning both researchers and participants know the treatment being administered. No placebo or comparator groups are involved in this phase 2 research. During the study, participants will undergo assessments to monitor safety and tolerability from the initial dose through the end of treatment. Researchers will also evaluate the effectiveness of ML-007C-MA in managing schizophrenia symptoms. The study involves outpatient care, regular clinical interviews, and the involvement of reliable informants to support assessments. Participants will be observed for up to one year to gather comprehensive data on long-term treatment outcomes.
CONDITIONS
Brief Title
A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able and willing to provide informed consent for all required study procedures.
- Has a primary diagnosis of schizophrenia based on DSM-5 criteria confirmed by a clinical interview.
- May benefit from long-term pharmacotherapy for schizophrenia as assessed by the investigator.
- Suitable for outpatient care and resides in a stable living situation.
- Has a reliable informant available to assist with assessments, who may be site staff with regular contact for over 1 year.
You will not qualify if you...
- Has any DSM-5 disorder other than schizophrenia within 12 months before screening that is mainly responsible for symptoms or impairment.
- Is stopping effective and well-tolerated antipsychotic therapy to join the study.
- Has received prohibited therapy during screening unless stopped before baseline.
- Has clinically significant or unstable medical conditions at screening or baseline.
- Has abnormal physical exam, ECG, or safety lab results at screening or baseline.
- Has an elevated risk of suicidal behavior.
- Is allergic to ML-007C-MA or its ingredients.
- Has moderate to severe substance use disorder (except tobacco or caffeine) within 12 months before screening.
- Has an elevated risk of violent or destructive behavior based on history and investigator judgment.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive ML-007C-MA dosed as 210/3 mg twice daily to treat schizophrenia.
Regular visits as per study protocol
Trial Site Locations
Total: 5 locations
1
Clinical Site
Lemon Grove, California, United States, 91945
Actively Recruiting
2
Clinical Site
Miami Lakes, Florida, United States, 33016
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3
Clinical Site
Chicago, Illinois, United States, 60640
Actively Recruiting
4
Clinical Site
Staten Island, New York, United States, 10314
Actively Recruiting
5
Clinical Site
DeSoto, Texas, United States, 75115
Actively Recruiting
Research Team
C
Clinical Trials Contact Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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