Clinical trials: sponsored by 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
Stable Schizophrenia
A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia
The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to…
- Trial name
- NCT03319953
- Testing
- TAK-041, Second Generation Antipsychotics (SGA)
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- Neurocrine Biosciences
Healthy Volunteers
A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS)
The purpose of this study is to determine brain penetration of single oral doses of TAK-041 and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).
- Trial name
- NCT02959892
- Testing
- Amphetamine, TAK -041, [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Depressive Disorder
TAK-653 Escalating Single and Multiple Dose Study in Healthy Participants
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of TAK-653 when administered as single and multiple oral doses at escalating dose levels in healthy participants.
- Trial name
- NCT02561156
- Testing
- TAK-653
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment.
- Trial name
- NCT02679079
- Testing
- NBI-98854
- Where
- 44 sites in United States
- Volunteers
- 98 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia (TD)
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
- Trial name
- NCT03698331
- Testing
- Valbenazine
- Where
- 17 sites in United States, Puerto Rico
- Volunteers
- 89 people
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment.
- Trial name
- NCT02581865
- Testing
- NBI-98854
- Where
- 30 sites in United States
- Volunteers
- 124 people
- Sponsor
- Neurocrine Biosciences
Parkinson's Disease
Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's Disease
Safety study of AADC gene transfer (VY-AADC01) in subjects with Parkinson's disease.
- Trial name
- AADC (NCT01973543)
- Testing
- VY-AADC01
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Neurocrine Biosciences
Parkinson Disease
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects…
- Trial name
- NCT03496870
- Testing
- Opicapone, Carbidopa Levodopa
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until…
- Trial name
- NCT02736955
- Testing
- Valbenazine
- Where
- 27 sites in United States
- Volunteers
- 161 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment.
- Trial name
- Kinect 4 (NCT02405091)
- Testing
- NBI-98854
- Where
- 48 sites in United States, Canada and 1 more
- Volunteers
- 167 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one…
- Trial name
- RE-Kinect (NCT03062033)
- Where
- 34 sites in United States
- Volunteers
- 70 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
- Trial name
- NCT01688037
- Testing
- NBI-98854
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 109 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD)…
- Trial name
- NCT01733121
- Testing
- NBI-98854
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 102 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or…
- Trial name
- NCT01393600
- Testing
- NBI-98854
- Where
- 11 sites in United States
- Volunteers
- 37 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
- Trial name
- KINECT 3 (NCT02274558)
- Testing
- NBI-98854
- Where
- 54 sites in United States, Canada and 1 more
- Volunteers
- 234 people
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome (TS).
- Trial name
- T-FORCE (NCT02256475)
- Testing
- NBI-98854
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Neurocrine Biosciences
Congenital Adrenal Hyperplasia
Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia
This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with congenital adrenal hyperplasia (CAH).
- Trial name
- NCT02349503
- Testing
- NBI-77860
- Where
- 2 sites in United States
- Sponsor
- Neurocrine Biosciences
Insomnia
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel…
- Trial name
- NCT00525941
- Testing
- NBI-34060
- Where
- 4 sites in United States
- Sponsor
- Neurocrine Biosciences