SchizophreniaPhase 2NCT07038876
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia
A Phase 2 study testing ML-007C-MA BID and ML-007C-MA QD in people with Schizophrenia, run by MapLight Therapeutics at 24 sites in United States.
Trial summary
ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ML-007C-MA BID and ML-007C-MA QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 24 sitesUnited States
- Study dates
- 27 Jun 2025to 11 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant 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).
- Participant may benefit from hospitalization or is currently hospitalized due to an acute exacerbation of schizophrenia symptoms, with exacerbation onset within 2 months of Screening. If the participant is already hospitalized for acute exacerbation of schizophrenia at Screening, they must have been inpatient for less than 2 weeks at the start of Screening.
- At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S.
- Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements.
Who cannot join
- Participant has any DSM-5 disorder, other than schizophrenia, within 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
- Participant has any psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before Screening and/or current involuntary hospitalization or incarceration.
- Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline.
- Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
- Participant is at an elevated risk of suicidal behavior.
- Participant has a known or likely allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients or has a known or likely severe allergic reaction (eg, anaphylactic reaction, angioedema) to any drug that could pose a risk to the participant in this study.
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- Participant 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 International Neuropsychiatric Interview).
- Participation in a clinical research study involving the administration of an investigational or marketed drug, biological product, or device within 90 days of Baseline, or concomitant active participation in an investigational study involving no drug, biological product, or device. Participants who have previously participated in a study with ML-007 may not participate.
- Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Clinical Site
Atlanta, Georgia, 30331
Clinical Site
Austin, Texas, 78754
Clinical Site
Bellflower, California, 90706
Clinical Site
Chicago, Illinois, 60640
Clinical Site
Culver City, California, 90230
Clinical Site
Decatur, Georgia, 30030
Clinical Site
DeSoto, Texas, 75115
Clinical Site
Garden Grove, California, 92845
Clinical Site
Hollywood, Florida, 33024
Clinical Site
Lemon Grove, California, 91945
Clinical Site
Little Rock, Arkansas, 72211
Clinical Site
Los Angeles, California, 90015
Clinical Site
Marlton, New Jersey, 08053
Clinical Site
Miami Lakes, Florida, 33016
Clinical Site
Montclair, California, 91763
Clinical Site
North Canton, Ohio, 44720
Clinical Site
Orange, California, 92868
Clinical Site
Richardson, Texas, 75080
Clinical Site
Riverside, California, 92506
Clinical Site
San Diego, California, 92123
Clinical Site
Sherman Oaks, California, 91403
Clinical Site
Staten Island, New York, 10314
Clinical Site
Torrance, California, 90504
Clinical Site
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Orally Administered ML-007C-MA in Inpatient Adult Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis
ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis.
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
- Conditions
- Schizophrenia
- Being tested
- Placebo, ML-007C-MA BID, ML-007C-MA QD
- Keywords
- Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders, Mental Disorders, Psychotic Disorders, Schizophrenia, Muscarinic Antagonists, Muscarinic Agonists, Cholinergic Agents, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matched Placebo
ML-007C-MA BIDDrug
ML-007C-MA dosed as 210/3 mg BID
ML-007C-MA QDDrug
ML-007C-MA dosed as 330/6 mg QD
| Study group | Role | What they receive |
|---|---|---|
| ML-007C-MA QD | Experimental | Not described Receives: Drug: ML-007C-MA QD |
| ML-007C-MA BID | Experimental | Not described Receives: Drug: ML-007C-MA BID |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Measured: Baseline and End of Treatment (5 weeks)
Secondary outcomes (3)
Change From Baseline to End of Treatment in CGI-S score
The CGI-S is a clinician-rated assessment of the severity of a participant's current illness on a 7-point scale, where a higher score is associated with greater severity. Values range from 1 (not ill at all) to 7 (among the most extremely ill).
Measured: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder positive factor score
The Positive Marder Factor score is derived from the PANSS and consists of the sum of 4 positive symptom items (P), one negative symptom item (N) and 3 general symptom items (G) (P1. Delusions; P3. Hallucinations; P5. Grandiosity; P6. Suspiciousness and persecution; N7. Stereotyped thinking; G1. Somatic concern; G9. Unusual thought content; G12. Lack of judgment and insight).
Measured: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder negative factor score
The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative symptom items (N) and 2 general symptom items (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.
Measured: Baseline and End of Treatment (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start27 Jun 2025
- Primary completion4 Jun 2026
- Study completion11 Jun 2026
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 307 participants (actual)
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
- NCT07038876
- Sponsor's protocol ID
- ML-007C-MA-211
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 9 Jul 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Orally Administered ML-007C-MA in Inpatient Adult Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis
- ClinicalTrials.gov ID
- NCT07038876
- Acronym / sponsor ID
- ML-007C-MA-211
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders, Mental Disorders, Psychotic Disorders, Schizophrenia, Muscarinic Antagonists, Muscarinic Agonists, Cholinergic Agents, Brain Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- MapLight TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 26 Jun 2025 (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-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis.
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ML-007C-MA QD | Experimental | Drug: ML-007C-MA QD |
| ML-007C-MA BID | Experimental | Drug: ML-007C-MA BID |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant 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).
- Participant may benefit from hospitalization or is currently hospitalized due to an acute exacerbation of schizophrenia symptoms, with exacerbation onset within 2 months of Screening. If the participant is already hospitalized for acute exacerbation of schizophrenia at Screening, they must have been inpatient for less than 2 weeks at the start of Screening.
- At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S.
- Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements.
Key exclusion criteria (9 listed)
- Participant has any DSM-5 disorder, other than schizophrenia, within 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
- Participant has any psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before Screening and/or current involuntary hospitalization or incarceration.
- Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline.
- Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
- Participant is at an elevated risk of suicidal behavior.
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 |
|---|---|---|
| PlaceboMatched Placebo | Drug | Placebo |
| ML-007C-MA BIDML-007C-MA dosed as 210/3 mg BID | Drug | ML-007C-MA BID |
| ML-007C-MA QDML-007C-MA dosed as 330/6 mg QD | Drug | ML-007C-MA QD |
Primary outcome
Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline and End of Treatment (5 weeks)
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
3 secondary outcomes
Change From Baseline to End of Treatment in CGI-S score
Time frame: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder positive factor score
Time frame: Baseline and End of Treatment (5 weeks)
Change From Baseline to End of Treatment in PANSS-Marder negative factor score
Time frame: Baseline and End of Treatment (5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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. This study is not recruiting at the moment.
MapLight Therapeutics study director
MapLight Therapeutics
24 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 BID and ML-007C-MA QD in people with Schizophrenia, run by MapLight Therapeutics at 24 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 4 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: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline and End of Treatment (5 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 9 Jul 2026.