A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
Recruiting · NCT07459647 · Interventional (participants receive a specific treatment) · Lead sponsor: MapLight Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
ML-007C-MA
What this trial is about
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).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Key
Exclusion criteria
- 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.
Where it is running
42 locations listed across 14 US states.
- Clinical Site - Little Rock, Arkansas, United States
- Clinical Site - Little Rock, Arkansas, United States
- Clinical Site - Rogers, Arkansas, United States
- Clinical Site - Bellflower, California, United States
- Clinical Site - Cerritos, California, United States
- Clinical Site - Culver City, California, United States
- Clinical Site - Garden Grove, California, United States
- Clinical Site - Lemon Grove, California, United States
- Clinical Site - Long Beach, California, United States
- Clinical Site - Los Angeles, California, United States
- Clinical Site - Montclair, California, United States
- Clinical Site - Oceanside, California, United States
- Clinical Site - Orange, California, United States
- Clinical Site - Pico Rivera, California, United States
- Clinical Site - Riverside, California, United States
- Clinical Site - San Diego, California, United States
- Clinical Site - Sherman Oaks, California, United States
- Clinical Site - Torrance, California, United States
- Clinical Site - Hollywood, Florida, United States
- Clinical Site - Hollywood, Florida, United States
- Clinical Site - Miami, Florida, United States
- Clinical Site - Miami Lakes, Florida, United States
- Clinical Site - West Palm Beach, Florida, United States
- Clinical Site - Atlanta, Georgia, United States
- Clinical Site - Decatur, Georgia, United States
- Clinical Site - Chicago, Illinois, United States
- Clinical Site - Gaithersburg, Maryland, United States
- Clinical Site - Boston, Massachusetts, United States
- Clinical Site - Watertown, Massachusetts, United States
- Clinical Site - Ann Arbor, Michigan, United States
- Clinical Site - Las Vegas, Nevada, United States
- Clinical Site - Las Vegas, Nevada, United States
- Clinical Site - Marlton, New Jersey, United States
- Clinical Site - New York, New York, United States
- Clinical Site - Staten Island, New York, United States
- Clinical Site - The Bronx, New York, United States
- Clinical Site - North Canton, Ohio, United States
- Clinical Site - West Chester, Ohio, United States
- Clinical Site - Philadelphia, Pennsylvania, United States
- Clinical Site - Austin, Texas, United States
- Clinical Site - DeSoto, Texas, United States
- Clinical Site - Richardson, Texas, United States