Clinical trials: sponsored by 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
Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
- Trial name
- NCT05110157
- Testing
- Valbenazine
- Where
- 87 sites in United States, Argentina and 2 more
- Volunteers
- 442 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
Major Depressive Disorder
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
- Trial name
- NCT06786624
- Testing
- NBI-1065845
- Where
- 18 sites in United States
- Volunteers
- 200 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
Schizophrenia
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with…
- Trial name
- NCT05545111
- Testing
- NBI-1117568
- Where
- 15 sites in United States
- Volunteers
- 210 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
- Trial name
- ERUDITE (NCT05182476)
- Testing
- Luvadaxistat
- Where
- 49 sites in United States, Bulgaria and 3 more
- Volunteers
- 216 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
Major Depressive Disorder
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.
- Trial name
- SAVITRI (NCT05203341)
- Testing
- NBI-1065845
- Where
- 41 sites in United States, Bulgaria and 4 more
- Volunteers
- 183 people
- Sponsor
- Neurocrine Biosciences
Parkinson's Disease
VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)
The objective of this study is to assess the safety of VY-AADC02 in participants with Parkinson's disease (PD) with motor fluctuations.
- Trial name
- NCT03562494
- Testing
- VY-AADC02
- Where
- 11 sites in United States
- Volunteers
- 14 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
- Trial name
- NCT05654870
- Testing
- Valbenazine
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Focal Onset Seizure, Focal Onset Epilepsy
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
- Trial name
- NCT05159908
- Testing
- NBI-921352
- Where
- 28 sites in Australia, Belgium and 5 more
- Volunteers
- 101 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
Focal Onset Seizure, Focal Onset Epilepsy
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11…
- Trial name
- NCT05493293
- Testing
- NBI-921352
- Where
- 26 sites in Australia, Belgium and 5 more
- Volunteers
- 82 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
Parkinson's Disease
Observational, Long-term Extension Study for Participants of Prior VY-AADC01 Studies
An extension study for participants who have completed a prior VY-AADC01 clinical study
- Trial name
- NCT03733496
- Where
- 3 sites in United States
- Volunteers
- 14 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