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Also known as TAK-831 Suspension, TAK-831 Oral Tablet, Luvadaxistat, NBI-1065844
TAK-831 · 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...
TAK-831 is an investigational small molecule being studied for the treatment of Friedreich Ataxia, a rare inherited neurodegenerative disorder. It is being developed by Neurocrine Biosciences, Inc. and has been evaluated in a Phase 2 clinical trial in adults with Friedreich Ataxia. It is not approved for any indication.
TAK-831 targets D-Amino Acid Oxidase, an enzyme that regulates levels of D-serine in the brain. By inhibiting this enzyme, TAK-831 is designed to modulate NMDA receptor signaling. This mechanism is being explored as a potential therapeutic approach for Friedreich Ataxia.
TAK-831 is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker symbol NBIX. The company is responsible for the clinical development of TAK-831 for Friedreich Ataxia.
TAK-831 is in Phase 2 clinical development for Friedreich Ataxia. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency for any indication.
TAK-831 has been evaluated in a Phase 2 clinical trial, NCT03214588, titled "Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia." The trial was completed and enrolled 67 participants in the United States. It was randomized, double-blind, and placebo-controlled.
Yes, TAK-831 Suspension and TAK-831 Oral Tablet are alternative names for TAK-831, referring to different oral formulations of the same investigational drug. TAK-831 is the base name used in clinical development for Friedreich Ataxia.