Clinical trials: sponsored by Neurocrine Biosciences
SCN8A Developmental and Epileptic Encephalopathy Syndrome
Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE
Extension study to evaluate how safe and tolerable the drug NBI-921352 is when used as adjunctive therapy in participants with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).
- Trial name
- NCT05226780
- Testing
- NBI-921352
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- 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
Dyskinesia, Cerebral Palsy
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.
- Trial name
- NCT05206513
- Testing
- Valbenazine
- Where
- 38 sites in United States, Argentina and 8 more
- Volunteers
- 86 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
- Trial name
- NCT06963034
- Testing
- NBI-1117568
- Where
- 21 sites in United States
- Volunteers
- 284 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
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
Trichotillomania (Hair-Pulling Disorder)
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a…
- Trial name
- NCT05207085
- Testing
- Valbenazine Oral Capsule
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Yale University
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
Tardive Dyskinesia
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
This will be an Investigator-initiated pilot study in which participants will be assessed with various scales to measure demoralization, anxiety, depression, and subjective incompetence at baseline and every two weeks after…
- Trial name
- NCT05053321
- Testing
- Valbenazine
- Where
- United States
- Sponsor
- Yale University
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
Drug-Induced Movement Disorder
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs).
- Trial name
- NCT06060444
- Testing
- Telemedicine Consult, In-person Consult
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Vermont
Tardive Dyskinesia, Intellectual Disability
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD).
- Conditions
- Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities
- Trial name
- TD-AIDD (NCT06107829)
- Testing
- Valbenazine Oral Capsule
- Where
- United States
- Sponsor
- Stephen Ruedrich