Clinical trials: sponsored by Neurocrine Biosciences
Parkinson Disease
Opicapone Treatment Initiation Open-Label Study
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with…
- Trial name
- OPTI-ON (NCT04787965)
- Testing
- Opicapone
- Where
- 6 sites in United States
- Volunteers
- 239 people
- Sponsor
- Neurocrine Biosciences
Essential Tremor
Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential Tremor
The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor.
- Trial name
- NCT04880616
- Testing
- NBI-827104
- Where
- Netherlands
- Volunteers
- 31 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
Idiopathic Parkinson's Disease, Parkinson's Disease
Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's Disease
Safety and efficacy of AADC gene transfer in participants with Parkinson's disease.
- Conditions
- Idiopathic Parkinson's Disease, Parkinson's Disease, Basal Ganglia Disease, Brain Diseases
- Trial name
- NCT03065192
- Testing
- VY-AADC01
- Where
- 4 sites in United States
- Volunteers
- 16 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 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
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
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
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
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
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
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
A Study to Evaluate Central Nervous System (CNS) Pharmacodynamic Activity of TAK-653 in Healthy Participants Using Transcranial Magnetic Stimulation (TMS)
The primary purpose of this study is to determine whether TAK-653, in comparison to placebo, increases CNS excitability, assessed with TMS-evoked motor-evoked potential (MEP) in healthy participants.
- Trial name
- NCT03792672
- Testing
- TAK-653, Ketamine
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- 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