Approval Probability
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Also known as ML-007C-MA BID
ML-007C-MA · 4 trials · 2 indications
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
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.
| Arm | Type | Description |
|---|---|---|
| ML-007C-MA | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ML-007C-MA QD | EXPERIMENTAL | - |
| ML-007C-MA BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ML-007C-MA | DRUG | ML-007C-MA dosed as 210/3 mg BID |
| Placebo | DRUG | Placebo Tablets |
| ML-007C-MA BID | DRUG | ML-007C-MA dosed as 210/3 mg BID |
| ML-007C-MA QD | DRUG | ML-007C-MA dosed as 330/6 mg QD |
Key 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...
ML-007C-MA is an investigational small molecule developed by MapLight Therapeutics, Inc. for psychiatric conditions. It is being studied in Phase 2 clinical trials for psychosis associated with Alzheimer's disease and for schizophrenia. It has received a Fast Track designation from the FDA.
ML-007C-MA is being evaluated for the treatment of psychosis associated with Alzheimer's disease. Two Phase 2 trials are studying it in this indication: NCT06887192, a placebo-controlled efficacy and safety study, and NCT07459660, an open-label study. It is investigational and has not been approved for this use.
ML-007C-MA targets M1 and M4 muscarinic receptors. It is a small molecule that acts on these receptors, which are involved in psychiatric and cognitive function. This receptor-targeting approach distinguishes it from standard dopamine-based antipsychotic treatments.
ML-007C-MA is being developed by MapLight Therapeutics, Inc., which trades under the ticker MPLT. The company is running Phase 2 clinical trials of the drug in schizophrenia and in psychosis associated with Alzheimer's disease.
ML-007C-MA is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program includes completed and ongoing Phase 2 trials in schizophrenia and psychosis associated with Alzheimer's disease, with a total enrollment of 807 participants across four studies.
ML-007C-MA is being studied in four Phase 2 trials. NCT07038876, completed, evaluated inpatient adults with schizophrenia. NCT07459647 is a long-term open-label schizophrenia study. NCT06887192 is a placebo-controlled Alzheimer's disease psychosis trial, and NCT07459660 is an open-label Alzheimer's disease psychosis study.
Yes. ML-007C-MA BID is an alternative name for ML-007C-MA. BID refers to twice-daily dosing. Both names refer to the same investigational small molecule developed by MapLight Therapeutics for schizophrenia and psychosis associated with Alzheimer's disease.