Clinical trials: sponsored by Neurocrine Biosciences
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency.
- Trial name
- CAHtalyst (NCT04490915)
- Testing
- Crinecerfont
- Where
- 70 sites in United States, Austria and 16 more
- Volunteers
- 182 people
- Sponsor
- Neurocrine Biosciences
Epileptic Encephalopathy, Continuous Spike and Wave During Sleep
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).
- Trial name
- Steamboat 2 (NCT05301894)
- Testing
- NBI-827104
- Where
- 12 sites in United States, Denmark and 3 more
- Volunteers
- 19 people
- Sponsor
- 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
SCN8A Developmental and Epileptic Encephalopathy Syndrome
Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
The objective of this study is to assess the efficacy, safety, and pharmacokinetics of NBI-921352 as adjunctive therapy for seizures in subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE).
- Trial name
- NCT04873869
- Testing
- NBI-921352
- Where
- 4 sites in United States
- Volunteers
- 8 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
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due…
- Trial name
- NCT04806451
- Testing
- Crinecerfont
- Where
- 46 sites in United States, Belgium and 8 more
- Volunteers
- 103 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
Tourette Syndrome
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
- Trial name
- NCT03530293
- Testing
- Valbenazine
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 81 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
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with…
- Trial name
- NCT03732534
- Testing
- NBI-98854
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 6 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
Schizophrenia, Cerebellar Ataxia
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
- Trial name
- NCT02566759
- Testing
- TAK-831 Oral Suspension, TAK-831 Tablet
- Where
- United Kingdom
- Volunteers
- 110 people, healthy volunteers welcome
- 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