ML-007C-MA for Schizophrenia

Recruiting at 24 trial locations

Overseen By Clinical Trials Contact Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: MapLight Therapeutics

Must not be taking: Antipsychotics

Disqualifiers: Substance use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill, ML-007C-MA, to determine its effectiveness in treating schizophrenia, particularly for those experiencing a sudden worsening of symptoms. The main goal is to assess whether this treatment reduces symptoms more effectively than a placebo (a pill with no active medicine). Participants should have schizophrenia with poorly controlled symptoms and should currently be in or need hospitalization due to a recent flare-up. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that participants stop taking any antipsychotic medication or prohibited therapy before the start of the study. It doesn't specify other medications, so you should discuss your current medications with the study team.

Is there any evidence suggesting that ML-007C-MA is likely to be safe for humans?

Research has shown that ML-007C-MA is likely a well-tolerated treatment. In earlier studies, patients using ML-007C-MA did not report any serious side effects. These studies assessed the drug's safety and tolerability, and the results indicated that the treatment was generally safe. ML-007C-MA has also been studied for other conditions, further confirming its safety profile.

Although this drug is still under investigation, its progression to a Phase 2 trial indicates it has already demonstrated some safety in earlier tests. This phase focuses more on the drug's efficacy, but safety remains crucial. So far, findings suggest ML-007C-MA is promising as a safe treatment option for those with schizophrenia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Researchers are excited about ML-007C-MA for schizophrenia because it offers a fresh approach compared to current treatments like antipsychotics such as risperidone or olanzapine. Unlike these existing options, which mainly target dopamine receptors, ML-007C-MA is designed to work on different pathways, potentially offering improved symptom control with fewer side effects. This could be a game-changer for patients who struggle with the efficacy or tolerability of existing medications. Additionally, one of the experimental arms involves a once-daily dosage, which could improve convenience and adherence for patients.

What evidence suggests that ML-007C-MA might be an effective treatment for schizophrenia?

Research shows that ML-007C-MA, which participants in this trial may receive, may help treat symptoms of schizophrenia. This treatment targets specific brain receptors that affect mood and perception, potentially reducing symptoms like hallucinations and delusions. Earlier studies found ML-007C-MA effective in reducing hyperactivity related to brain function problems. Although more research is needed specifically for schizophrenia, these findings suggest it could help manage symptoms. Initial results from studies on other conditions, such as Alzheimer's disease psychosis, also indicate that it is well-tolerated and potentially effective. ^{2 3 5 6 7}

Who Is on the Research Team?

MapLight Therapeutics

Principal Investigator

MapLight Therapeutics

Are You a Good Fit for This Trial?

Adults aged 18 to 64 who are hospitalized due to an acute episode of schizophrenia can join this study. They should be experiencing symptoms that aren't well-controlled. People with certain genetic disorders like SHOX deficiency or those taking other treatments for psychosis may not qualify.

Inclusion Criteria

I have been diagnosed with schizophrenia by a clinical interview.

I am hospitalized or may need hospitalization due to worsening schizophrenia symptoms that started less than 2 months ago.

My schizophrenia symptoms are moderate to severe and ongoing.

Exclusion Criteria

Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ML-007C-MA or placebo for 5 weeks to assess efficacy, safety, and tolerability

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ML-007C-MA

Trial Overview The trial is testing ML-007C-MA, a new oral medication given once (QD) or twice daily (BID), against a placebo to see if it's better at managing the symptoms of schizophrenia using the PANSS Total Score as a measure.

How Is the Trial Designed?

Group I: ML-007C-MA 330/6 mg QD Experimental Treatment 1 Intervention

Group II: ML-007C-MA 210/3 mg BID Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

MapLight Therapeutics

Lead Sponsor

Trials

3

Recruited

570+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06887192

A Study to Assess the Efficacy and Safety of ML-007C-MA ... The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as ...

2. maplightrx.com maplightrx.com/maplight-therapeutics-announces-ml-007c-ma-phase-2-initiation-alzheimers-disease-psychosis/

MapLight Therapeutics Announces Initiation of Phase 2 ... ML-007C-MA offers the potential to be a well-tolerated treatment option with convenient dosing, while achieving or exceeding CSF exposures ...

3. nature.com nature.com/articles/s41386-025-02256-3

Preclinical efficacy of the muscarinic agonist ML-007 in ... Our results indicate that ML-007 is effective at reducing hyperlocomotion resulting from aberrant activity in basal ganglia circuitry, further ...

4. prnewswire.com prnewswire.com/news-releases/maplight-therapeutics-announces-initiation-of-phase-2-trial-of-novel-m1m4-muscarinic-agonist-ml-007c-ma-for-the-treatment-of-alzheimers-disease-psychosis-302559110.html

MapLight Therapeutics Announces Initiation of Phase 2 ... MapLight Therapeutics Announces Initiation of Phase 2 Trial of Novel M1/M4 Muscarinic Agonist ML-007C-MA for the Treatment of Alzheimer's ...

5. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-the-efficacy-and-safety-of-ml-007c-ma-for-the-treatment-of-alzheimers-disease-psy

A Study to Assess the Efficacy and Safety of ML-007C-MA for ... The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07038876

A Study to Assess the Efficacy and Safety of ML-007C-MA ... ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ...

7. maplightrx.com maplightrx.com/maplight-therapeutics-announces-results-from-phase-1-trial/

MapLight Therapeutics Announces Results from Phase 1 ... MapLight Therapeutics today announced results from its Phase 1 trial evaluating the safety, tolerability and pharmacokinetics of ML-007/PAC ...