Clinical trials: sponsored by Neurocrine Biosciences
Major Depressive Disorder
A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in…
- Trial name
- NCT07196501
- Testing
- Osavampator
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 550 people
- Sponsor
- Neurocrine Biosciences
Congenital Adrenal Hyperplasia
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adult Participants With Classic Congenital Adrenal Hyperplasia (CAH)
The main objective of this study is to evaluate the efficacy of different dose levels of NBIP-01435 on reducing elevated androstenedione (A4) levels in adults with classic CAH.
- Trial name
- NCT07850739
- Testing
- NBIP-01435
- Volunteers
- 36 people
- Sponsor
- Neurocrine Biosciences
Bipolar I Disorder, Mania
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or…
- Trial name
- NCT07288320
- Testing
- NBI-1117568
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
NBI-1117568-SCZ3030: 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
- NCT07105098
- Testing
- NBI-1117568
- Where
- 20 sites in United States, Bulgaria and 3 more
- Volunteers
- 284 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
- Trial name
- NCT07114874
- Testing
- NBI-1117568
- Where
- 61 sites in United States, Bulgaria and 3 more
- Volunteers
- 600 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.
- Trial name
- NCT07227818
- Testing
- NBI-1117568
- Where
- 25 sites in United States, Puerto Rico and 1 more
- Volunteers
- 560 people
- Sponsor
- Neurocrine Biosciences
Alzheimer's Disease
Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor
This study is designed to evaluate the efficacy on improving cognitive performance as well as the safety, tolerability, and pharmacokinetics (PK) of NBI-1117567 administered once daily (QD) in adults with mild to moderate AD who…
- Trial name
- NCT07832383
- Testing
- NBI-1117567
- Volunteers
- 135 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia, Schizoaffective Disorder
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder
- Trial name
- NCT07105111
- Testing
- Valbenazine
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Neurocrine Biosciences
Major Depressive Disorder
NBI-1065845-MDD3025: 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
- NCT06911112
- Testing
- NBI-1065845
- Where
- 39 sites in United States, Bulgaria and 3 more
- Volunteers
- 200 people
- Sponsor
- Neurocrine Biosciences
Major Depressive Disorder
NBI-1065845-MDD3026: 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
- NCT06963021
- Testing
- NBI-1065845
- Where
- 35 sites in United States, Belgium and 5 more
- Volunteers
- 200 people
- Sponsor
- Neurocrine Biosciences
Major Depressive Disorder
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
- Trial name
- NCT06966401
- Testing
- NBI-1065845
- Where
- 106 sites in United States, Belgium and 18 more
- Volunteers
- 850 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
- Trial name
- NCT07288333
- Testing
- NBI-1117570
- Where
- 6 sites in Bulgaria, Romania and 1 more
- Volunteers
- 120 people
- Sponsor
- Neurocrine Biosciences
Major Depressive Disorder
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).
- Trial name
- NCT06267846
- Testing
- NBI-1070770
- Where
- 13 sites in United States
- Volunteers
- 73 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.
- Trial name
- NCT07365462
- Testing
- NBI-1065890
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- Neurocrine Biosciences
Chorea, Huntington
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.
- Trial name
- NCT06312189
- Testing
- Valbenazine
- Where
- 3 sites in Canada
- Volunteers
- 7 people
- Sponsor
- Neurocrine Biosciences
Chorea, Huntington
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.
- Trial name
- NCT04400331
- Testing
- Valbenazine
- Where
- 34 sites in United States, Canada
- Volunteers
- 154 people
- Sponsor
- 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