Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...