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Also known as TAK-831, NBI-1065844, TAK-831 Oral Tablet
Luvadaxistat · 3 trials · 2 indications
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.
The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.
| 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). |
| TAK-831 75 mg | EXPERIMENTAL | TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks. |
| TAK-831 300 mg | EXPERIMENTAL | TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Luvadaxistat | DRUG | TAK-831 Tablets. |
| Matching Placebo | DRUG | Matching Placebo Tablets. |
| Placebo | DRUG | Luvadaxistat placebo-matching tablets. |
| TAK-831 | DRUG | TAK-831 tablets |
| TAK-831 Placebo | DRUG | TAK-831 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...
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Luvadaxistat is an investigational small molecule being studied for the treatment of schizophrenia, specifically for negative symptoms. It is being developed by Neurocrine Biosciences, Inc. and has been evaluated in Phase 2 clinical trials in adults with schizophrenia. It is not approved for any indication.
Luvadaxistat is a small molecule that targets an enzyme in the -stat class. Enzyme inhibition of this type is the mechanism under investigation for treating negative symptoms of schizophrenia. The drug is orally administered and was studied in adults aged 18 years and older.
Luvadaxistat is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company is the sponsor of the clinical program evaluating the drug in schizophrenia.
Luvadaxistat is in Phase 2 development. Two Phase 2 trials have been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
Luvadaxistat has been studied in two completed Phase 2 trials: NCT03382639, which evaluated three dose levels in 256 adults with negative symptoms of schizophrenia across the United States, Bulgaria, Czechia, Germany, Italy, Poland, Spain, and Ukraine, and NCT03359785, which evaluated multiple oral doses in 31 adults with schizophrenia in the United States.
Yes. Both Phase 2 trials of Luvadaxistat were randomized, double-blind, and placebo-controlled. Together they enrolled 287 adults aged 18 years and older with schizophrenia. Neither trial used biomarker selection, and healthy volunteers were not enrolled.