SchizophreniaPhase 2NCT07459647
A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
A Phase 2 study testing ML-007C-MA in people with Schizophrenia, run by MapLight Therapeutics at 45 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ML-007C-MA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 45 sitesUnited States
- Study dates
- 31 Mar 2026to Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
United States45 sites, 45 recruiting
- Recruiting
Clinical Site
Ann Arbor, Michigan, 48105
- Recruiting
Clinical Site
Atlanta, Georgia, 30331
- Recruiting
Clinical Site
Austin, Texas, 78754
- Recruiting
Clinical Site
Bellflower, California, 90706
- Recruiting
Clinical Site
Boston, Massachusetts, 02116
- Recruiting
Clinical Site
Cedarhurst, New York, 11516
- Recruiting
Clinical Site
Cerritos, California, 90703
- Recruiting
Clinical Site
Chicago, Illinois, 60640
- Recruiting
Clinical Site
Culver City, California, 90230
- Recruiting
Clinical Site
Decatur, Georgia, 30030
- Recruiting
Clinical Site
DeSoto, Texas, 75115
- Recruiting
Clinical Site
Flowood, Mississippi, 39232
- Recruiting
Clinical Site
Gaithersburg, Maryland, 20877
- Recruiting
Clinical Site
Garden Grove, California, 92845
- Recruiting
Clinical Site
Hollywood, Florida, 33021
- Recruiting
Clinical Site
Hollywood, Florida, 33024
- Recruiting
Clinical Site
Houston, Texas, 77081
- Recruiting
Clinical Site
Las Vegas, Nevada, 89119
- Recruiting
Clinical Site
Lemon Grove, California, 91945
- Recruiting
Clinical Site
Little Rock, Arkansas, 72204
- Recruiting
Clinical Site
Little Rock, Arkansas, 72211
- Recruiting
Clinical Site
Long Beach, California, 90807
- Recruiting
Clinical Site
Los Angeles, California, 90015
- Recruiting
Clinical Site
Marlton, New Jersey, 08053
- Recruiting
Clinical Site
Miami, Florida, 33135
- Recruiting
Clinical Site
Miami, Florida, 33166
- Recruiting
Clinical Site
Miami Lakes, Florida, 33016
- Recruiting
Clinical Site
Montclair, California, 91763
- Recruiting
Clinical Site
New York, New York, 10029
- Recruiting
Clinical Site
North Canton, Ohio, 44720
- Recruiting
Clinical Site
Oceanside, California, 92056
- Recruiting
Clinical Site
Orange, California, 92868
- Recruiting
Clinical Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Clinical Site
Pico Rivera, California, 94596
- Recruiting
Clinical Site
Richardson, Texas, 75080
- Recruiting
Clinical Site
Riverside, California, 92506
- Recruiting
Clinical Site
Rogers, Arkansas, 72758
- Recruiting
Clinical Site
San Diego, California, 92123
- Recruiting
Clinical Site
Sherman Oaks, California, 91403
- Recruiting
Clinical Site
Staten Island, New York, 10314
- Recruiting
Clinical Site
The Bronx, New York, 10641
- Recruiting
Clinical Site
Torrance, California, 90504
- Recruiting
Clinical Site
Watertown, Massachusetts, 02472
- Recruiting
Clinical Site
West Chester, Ohio, 45069
- Recruiting
Clinical Site
West Palm Beach, Florida, 33407
About this study
Official title: 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).
- Conditions
- Schizophrenia
- Being tested
- ML-007C-MA
- Keywords
- Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders, Mental Disorders, Psychotic Disorders, Schizophrenia, Muscarinic Antagonists, Muscarinic Agonists, Cholinergic Agents, Nervous System Diseases, Central Nervous System Diseases, Brain Diseases
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders, Nervous System Diseases, Central Nervous System Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-007C-MADrug
ML-007C-MA dosed as 210/3 mg BID
| Study group | Role | What they receive |
|---|---|---|
| ML-007C-MA | Experimental | Not described Receives: Drug: ML-007C-MA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initial dose through end of treatment (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start31 Mar 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MapLight Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MapLight Therapeutics, Study director, MapLight Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459647
- Sponsor's protocol ID
- ML-007C-MA-212
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia
- ClinicalTrials.gov ID
- NCT07459647
- Acronym / sponsor ID
- ML-007C-MA-212
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders, Mental Disorders, Psychotic Disorders, Schizophrenia, Muscarinic Antagonists, Muscarinic Agonists, Cholinergic Agents, Nervous System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MapLight TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ML-007C-MA | Experimental | Drug: ML-007C-MA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ML-007C-MAML-007C-MA dosed as 210/3 mg BID | Drug | ML-007C-MA |
Primary outcome
To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia
Time frame: From initial dose through end of treatment (up to 52 weeks)
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MapLight Therapeutics study director
MapLight Therapeutics
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ML-007C-MA in people with Schizophrenia, run by MapLight Therapeutics at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Contact Center (+1 650 839 4385, ML-007C-MA-SCZ@maplightrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia (time frame: From initial dose through end of treatment (up to 52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.