ML-007C-MA for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ML-007C-MA to determine its safety and effectiveness for people with schizophrenia. Schizophrenia affects a person's thoughts, feelings, and behavior. The trial aims to understand how this treatment works over a year for those who might need long-term medication. Individuals with schizophrenia who can live outside a hospital in a stable situation might be suitable candidates for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that ML-007C-MA is likely to be safe for humans?
Research has shown that ML-007C-MA underwent safety testing in earlier studies. In one study with twice-daily doses, 270 participants generally tolerated the medication well, experiencing few side effects. Most people had no major issues with the treatment. Additionally, ML-007C-MA received Fast Track Designation from the FDA, indicating promise in earlier evaluations. While side effects can occur, the data so far suggest the treatment is reasonably safe for people.12345
Why do researchers think this study treatment might be promising for schizophrenia?
ML-007C-MA is unique because it offers a novel approach to treating schizophrenia by potentially targeting different pathways in the brain compared to existing medications like antipsychotics, which primarily modulate dopamine levels. Researchers are excited about ML-007C-MA because it may have a new mechanism of action that could provide benefits for patients who don't respond well to current treatments. Additionally, ML-007C-MA might offer fewer side effects or improved efficacy, making it a promising candidate for enhancing the quality of life for individuals living with schizophrenia.
What evidence suggests that ML-007C-MA might be an effective treatment for schizophrenia?
Research has shown that ML-007C-MA, the treatment under study in this trial, aims to alleviate schizophrenia symptoms by targeting specific brain receptors, M1 and M4. Early animal studies found ML-007 to be about ten times more effective than xanomeline in reducing symptoms in mice with psychosis. This finding suggests it might help manage symptoms like hallucinations and delusions in humans. Initial human studies, including this trial, focus on assessing its safety and effectiveness. Although complete results are not yet available, the promising animal data and targeted approach offer hope for its potential in treating schizophrenia.13567
Who Is on the Research Team?
MapLight Therapeutics
Principal Investigator
MapLight Therapeutics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ML-007C-MA for long-term safety, tolerability, and effectiveness evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ML-007C-MA
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
MapLight Therapeutics
Lead Sponsor
Citations
1.
psychiatrictimes.com
psychiatrictimes.com/view/fast-track-designation-granted-ml-007c-ma-for-alzheimer-disease-psychosisFast Track Designation Granted: ML-007C-MA for ...
ML-007C-MA targets hallucinations and delusions in Alzheimer's disease psychosis, activating M1/M4 muscarinic receptors while minimizing ...
registration statement under the securities act of 1933
We are currently conducting ZEPHYR, a Phase 2 trial evaluating ML-007C-MA for the treatment of schizophrenia, and expect topline results in the second half of ...
Preclinical efficacy of the muscarinic agonist ML-007 in ...
ML-007 was found to be about ten-fold more potent than xanomeline in three standard preclinical mouse models of psychosis. However, xanomeline ...
4.
maplightrx.com
maplightrx.com/maplight-therapeutics-announces-ml-007c-ma-phase-2-initiation-schizophrenia/MapLight Therapeutics Announces Initiation of Phase 2 ...
MapLight Therapeutics today announced the initiation of a Phase 2 study to evaluate the efficacy, safety and tolerability of ML-007C-MA, an investigational ...
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 in the treatment of subjects with inadequately controlled symptoms of ...
A Long-Term Open-Label Study of ML-007C-MA in Adults ...
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 ...
A Study to Assess the Efficacy and Safety of ML-007C-MA for ...
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 ...
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