Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03359785 | A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia | PHASE2 | COMPLETED | 31 | — | — | Jan 10, 2018 | Dec 21, 2020 | Feb 28, 2024 | 1 | United States |
| NCT03382639 | A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia | PHASE2 | COMPLETED | 256 | — | — | Jan 4, 2018 | Jan 12, 2021 | Feb 28, 2024 | 54 | United States, Bulgaria +6 |
EBC is a method used to investigate cerebellar-dependent learning. In EBC, a conditioned stimulus, a tone precedes but co-terminates with an unconditioned stimulus, an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response) occurs prior to the onset of the unconditioned stimulus. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned). Results are reported as least squares (LS) means at Day 8, determined using an analysis of variance (ANOVA).
PANSS assesses the positive symptoms, negative symptoms and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Here, the PANSS NSFS subscale consists of 7 items which assess the negative symptoms with subscale score ranging from 7 to 49, where a higher score indicates greater severity. Baseline was defined as the last observed value before the first dose of study treatment. Results are reported as least squares (LS) mean change from baseline at Week 12, determined using a mixed model for repeated measures (MMRM). A negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Luvadaxistat 500 mg, then Placebo | EXPERIMENTAL | Participants first received luvadaxistat 500 mg orally once daily (QD) for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2. |
| Placebo, then Luvadaxistat 500 mg | EXPERIMENTAL | Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 500 mg orally QD for 8 days during treatment period 2. |
| Luvadaxistat 50 mg, then Placebo | EXPERIMENTAL | Participants first received luvadaxistat 50 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2. |
| Placebo, then Luvadaxistat 50 mg | EXPERIMENTAL | Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 50 mg orally QD for 8 days during treatment period 2. |
| Luvadaxistat 50 milligrams (mg) | EXPERIMENTAL | Participants received luvadaxistat 50 mg orally once daily (QD) for 12 weeks (Days 1 to 84). |
| Luvadaxistat 125 mg | EXPERIMENTAL | Participants received luvadaxistat 125 mg orally QD for 12 weeks (Days 1 to 84). |
| Luvadaxistat 500 mg | EXPERIMENTAL | Participants received luvadaxistat 500 mg orally QD for 12 weeks (Days 1 to 84). |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo (matching luvadaxistat) orally QD for 12 weeks (Days 1 to 84). |
| Name | Type | Description |
|---|---|---|
| Luvadaxistat | DRUG | TAK-831 Tablets. |
| Matching Placebo | DRUG | Matching Placebo Tablets. |
| Placebo | DRUG | Luvadaxistat placebo-matching tablets. |
Inclusion Criteria: * Have a body mass index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 40.0 (kilogram per square meter \[kg/m\^2\]) at the Screening Visit. * With a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schi...