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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ML-007C-MA
  • Drug: ML-007C-MA
    ML-007C-MA dosed as 210/3 mg BID

Recruiting Locations

Clinical Site
Little Rock, Arkansas 72204

Clinical Site
Little Rock, Arkansas 72211

Clinical Site
Rogers, Arkansas 72758

Clinical Site
Bellflower, California 90706

Clinical Site
Cerritos, California 90703

Clinical Site
Culver City, California 90230

Clinical Site
Garden Grove, California 92845

Clinical Site
Lemon Grove, California 91945

Clinical Site
Long Beach, California 90807

Clinical Site
Los Angeles, California 90015

Clinical Site
Montclair, California 91763

Clinical Site
Oceanside, California 92056

Clinical Site
Orange, California 92868

Clinical Site
Pico Rivera, California 94596

Clinical Site
Riverside, California 92506

Clinical Site
San Diego, California 92123

Clinical Site
Sherman Oaks, California 91403

Clinical Site
Torrance, California 90504

Clinical Site
Hollywood, Florida 33021

Clinical Site
Hollywood, Florida 33024

Clinical Site
Miami, Florida 33166

Clinical Site
Miami Lakes, Florida 33016

Clinical Site
West Palm Beach, Florida 33407

Clinical Site
Atlanta, Georgia 30331

Clinical Site
Decatur, Georgia 30030

Clinical Site
Chicago, Illinois 60640

Clinical Site
Gaithersburg, Maryland 20877

Clinical Site
Boston, Massachusetts 02116

Clinical Site
Watertown, Massachusetts 02472

Clinical Site
Ann Arbor, Michigan 48105

Clinical Site
Las Vegas, Nevada 89119

Clinical Site
Marlton, New Jersey 08053

Clinical Site
New York, New York 10029

Clinical Site
Staten Island, New York 10314

Clinical Site
The Bronx, New York 10641

Clinical Site
North Canton, Ohio 44720

Clinical Site
West Chester, Ohio 45069

Clinical Site
Philadelphia, Pennsylvania 19104

Clinical Site
Austin, Texas 78754

Clinical Site
DeSoto, Texas 75115

Clinical Site
Richardson, Texas 75080

More Details

Status
Recruiting
Sponsor
MapLight Therapeutics

Study Contact

Clinical Trials Contact Center
+1 650 839 4385
ML-007C-MA-SCZ@maplightrx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.