Clinical trials: completed, sponsored by Neurocrine Biosciences
Schizophrenia, Schizoaffective Disorder
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder
- Trial name
- NCT05859698
- Testing
- Valbenazine
- Where
- 18 sites in United States
- Volunteers
- 59 people
- Sponsor
- Neurocrine Biosciences
Epileptic Encephalopathy, Continuous Spike and Wave During Sleep
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous…
- Trial name
- NCT04625101
- Testing
- NBI-827104
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 24 people
- Sponsor
- Neurocrine Biosciences
Anhedonia, Major Depressive Disorder
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).
- Trial name
- TERPSIS (NCT05165394)
- Testing
- NBI-1065846
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 93 people
- Sponsor
- Neurocrine Biosciences
CAH - Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
This is a Phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a…
- Trial name
- NCT04045145
- Testing
- Crinecerfont
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia
The purpose of this study is to determine whether luvadaxistat is superior to placebo in improving cerebellar function as measured with the average percentage of conditioned responses during the eyeblink conditioning (EBC) test.
- Trial name
- NCT03359785
- Testing
- Luvadaxistat
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia
The purpose of this study is to determine whether add-on luvadaxistat is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).
- Trial name
- NCT03382639
- Testing
- Luvadaxistat
- Where
- 54 sites in United States, Bulgaria and 6 more
- Volunteers
- 256 people
- Sponsor
- Neurocrine Biosciences
Chorea, Huntington
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with Huntington disease.
- Trial name
- KINECT-HD (NCT04102579)
- Testing
- Valbenazine
- Where
- 46 sites in United States, Canada
- Volunteers
- 128 people
- Sponsor
- Neurocrine Biosciences
CAH - Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in up to 30 adult female and male subjects (18 to 50 years of…
- Trial name
- NCT03525886
- Testing
- NBI-74788
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
- Trial name
- NCT03444038
- Testing
- Valbenazine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 85 people
- Sponsor
- Neurocrine Biosciences
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500…
- Trial name
- NCT04234672
- Testing
- TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, [14C]TAK-831 Oral Suspension
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a…
- Trial name
- NCT03325010
- Testing
- Valbenazine
- Where
- 35 sites in United States, Puerto Rico
- Volunteers
- 127 people
- Sponsor
- Neurocrine Biosciences
Healthy
Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration
The purpose of this study is to determine the relationship between TAK-831 dose, plasma exposure, extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following single oral dosing of TAK-831 in healthy…
- Trial name
- NCT02716987
- Testing
- TAK-831, [18F]PGM299
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Healthy Volunteers
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when…
- Trial name
- NCT03101293
- Testing
- TAK-831
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Friedreich Ataxia
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity.
- Trial name
- NCT03214588
- Testing
- TAK-831
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neurocrine Biosciences
Healthy
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.
- Trial name
- NCT03224325
- Testing
- TAK-831 Tablet T2, TAK-831 Suspension
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Healthy Volunteers
Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.
- Trial name
- NCT03687684
- Testing
- TAK-831
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Healthy Volunteers
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3…
- Trial name
- NCT03706469
- Testing
- TAK-831 T2, TAK-831 T3
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).
- Trial name
- NCT02879578
- Testing
- Valbenazine
- Where
- 13 sites in United States
- Volunteers
- 155 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia (TD)
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
- Trial name
- NCT03891862
- Testing
- Valbenazine
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 135 people
- Sponsor
- Neurocrine Biosciences
Healthy Volunteers, Schizophrenia
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2.
- Trial name
- NCT02748694
- Testing
- TAK-041
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences