Clinical Trials - NBIX

NCT IDTitleStatusPhasesStart DateCompletion DatePrimary Completion Date
NCT07187375Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years OldNOT_YET_RECRUITINGPHASE22025-09-282029-10-042029-09-06
NCT07105111A 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) InhibitorRECRUITINGPHASE42025-08-292027-042027-04
NCT07196501A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)RECRUITINGPHASE32025-08-182028-072028-07
NCT07105098NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaRECRUITINGPHASE32025-08-112027-112027-11
NCT07114874NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With SchizophreniaRECRUITINGPHASE32025-07-112031-122031-12
NCT06963021NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)RECRUITINGPHASE32025-05-302027-072027-07
NCT06963034NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaRECRUITINGPHASE32025-05-082027-102027-10
NCT06966401Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)RECRUITINGPHASE32025-04-162030-052029-05
NCT06911112NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)RECRUITINGPHASE32025-03-312027-072027-07
NCT06786624Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)RECRUITINGPHASE32025-01-222027-072027-07
NCT06312189Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in CanadaENROLLING_BY_INVITATIONPHASE32024-04-242026-042026-04
NCT06267846A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive DisorderACTIVE_NOT_RECRUITINGPHASE22024-03-202025-122025-09
NCT05859698Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive DyskinesiaCOMPLETEDPHASE42023-05-252024-12-272024-12-27
NCT05654870Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for SchizophreniaTERMINATEDPHASE32023-01-052023-11-082023-11-08
NCT05493293Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset SeizuresTERMINATEDPHASE22022-11-092024-03-112024-03-11
NCT05545111Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With SchizophreniaCOMPLETEDPHASE22022-10-042024-07-102024-07-10
NCT05226780Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEEACTIVE_NOT_RECRUITINGPHASE22022-07-122026-032026-03
NCT05301894Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepTERMINATEDPHASE22022-06-072025-01-272025-01-27
NCT05206513Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral PalsyACTIVE_NOT_RECRUITINGPHASE32022-04-152026-062025-12
NCT05203341Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)COMPLETEDPHASE22022-02-212024-02-212024-01-10
NCT04873869Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)TERMINATEDPHASE22022-01-312023-03-172023-03-17
NCT05182476Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With SchizophreniaTERMINATEDPHASE22021-12-072024-10-142024-06-28
NCT05165394Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDDCOMPLETEDPHASE22021-11-302023-09-132023-07-07
NCT05110157Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for SchizophreniaCOMPLETEDPHASE32021-11-292025-02-182025-02-04
NCT05159908A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset SeizuresCOMPLETEDPHASE22021-11-082023-08-212023-08-21
NCT04806451Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)ACTIVE_NOT_RECRUITINGPHASE32021-06-252027-082023-03-10
NCT04625101Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepCOMPLETEDPHASE22021-04-262022-10-112022-08-08
NCT04880616Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential TremorCOMPLETEDPHASE22021-04-202022-06-082022-05-25
NCT04490915Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal HyperplasiaACTIVE_NOT_RECRUITINGPHASE32020-12-162027-082023-07-19
NCT04400331Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington DiseaseACTIVE_NOT_RECRUITINGPHASE32020-09-182026-032026-03
NCT04234672A 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 ParticipantsCOMPLETEDPHASE12020-02-172020-04-042020-04-04
NCT04045145Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal HyperplasiaCOMPLETEDPHASE22019-12-122021-07-022021-07-02
NCT04102579Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington DiseaseCOMPLETEDPHASE32019-11-132021-10-262021-10-15
NCT03891862Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive DyskinesiaCOMPLETEDPHASE42019-03-182020-01-302019-12-23
NCT03792672A Study to Evaluate Central Nervous System (CNS) Pharmacodynamic Activity of TAK-653 in Healthy Participants Using Transcranial Magnetic Stimulation (TMS)COMPLETEDPHASE12019-02-112019-06-182019-05-15
NCT03706469A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy ParticipantsCOMPLETEDPHASE12018-10-182018-12-222018-12-11
NCT03562494VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)COMPLETEDPHASE12018-10-172024-10-302024-10-30
NCT03732534Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette SyndromeTERMINATEDPHASE22018-10-172019-02-182019-02-18
NCT03687684Phase 1 Study of TAK-831 in Healthy Adult Asian SubjectsCOMPLETEDPHASE12018-10-092019-06-192019-06-09
NCT03698331The Potential for Clinical Dependence and Withdrawal Symptoms Associated With ValbenazineCOMPLETEDPHASE42018-09-142019-04-032019-04-03
NCT03530293Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette SyndromeTERMINATEDPHASE22018-04-172019-07-162019-07-16
NCT03525886Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal HyperplasiaCOMPLETEDPHASE22018-04-102020-04-072020-04-07
NCT03444038Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette SyndromeCOMPLETEDPHASE22018-02-082019-07-122019-07-12
NCT03496870A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.COMPLETEDPHASE12018-02-082018-07-022018-07-02
NCT03359785A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With SchizophreniaCOMPLETEDPHASE22018-01-102020-12-212020-12-21
NCT03382639A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of SchizophreniaCOMPLETEDPHASE22018-01-042021-01-122020-12-29
NCT03319953A 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 SchizophreniaCOMPLETEDPHASE22017-12-212019-11-062019-09-11
NCT03214588Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich AtaxiaCOMPLETEDPHASE22017-11-082018-12-272018-12-27
NCT03325010Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette SyndromeCOMPLETEDPHASE22017-10-052018-11-162018-11-01
NCT03224325A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy ParticipantsCOMPLETEDPHASE12017-07-212018-09-092018-09-09
NCT03065192Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's DiseaseCOMPLETEDPHASE12017-05-112021-08-102021-08-10
NCT03101293A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet FormulationCOMPLETEDPHASE12017-04-042017-05-262017-05-19
NCT02959892A 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)COMPLETEDPHASE12016-12-052017-08-232017-05-30
NCT02879578Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette SyndromeCOMPLETEDPHASE22016-07-252017-11-012017-11-01
NCT02736955Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive DyskinesiaCOMPLETEDPHASE32016-06-132017-06-302017-06-30
NCT02748694Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics StudyCOMPLETEDPHASE12016-05-092019-09-222019-09-22
NCT02679079Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette SyndromeCOMPLETEDPHASE22016-03-232017-04-142017-04-14
NCT02716987Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral AdministrationCOMPLETEDPHASE12016-03-212016-08-302016-08-30
NCT02581865Safety and Efficacy Study of NBI-98854 in Adults With Tourette SyndromeCOMPLETEDPHASE22015-112016-122016-12
NCT02566759A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy ParticipantsTERMINATEDPHASE12015-09-232016-07-122016-06-09
NCT02561156TAK-653 Escalating Single and Multiple Dose Study in Healthy ParticipantsCOMPLETEDPHASE12015-08-262017-09-232017-09-11
NCT02405091Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive DyskinesiaCOMPLETEDPHASE32015-032017-032017-03
NCT02349503Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal HyperplasiaWITHDRAWNPHASE12015-022015-102015-10
NCT02274558A Phase 3 Study of NBI-98854 for the Treatment of Tardive DyskinesiaCOMPLETEDPHASE32014-102016-072015-09
NCT02256475Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette SyndromeCOMPLETEDPHASE12014-092015-122015-11
NCT01973543Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's DiseaseCOMPLETEDPHASE12013-102020-01-242020-01-24
NCT01916993Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic InsufficiencyCOMPLETEDPHASE12013-082013-122013-12
NCT01910480Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy SubjectsCOMPLETEDPHASE12013-072013-082013-08
NCT01733121NBI-98854 Dose Titration Study for the Treatment of Tardive DyskinesiaCOMPLETEDPHASE22012-122013-122013-12
NCT01688037NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)COMPLETEDPHASE22012-092013-102013-09
NCT01393600NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective DisorderCOMPLETEDPHASE22011-082012-022012-02
NCT01267188Efficacy and Safety of NBI-98854 in Subjects With Tardive DyskinesiaCOMPLETEDPHASE22011-012011-032011-03
NCT00525941An Exploratory Study of NBI-34060 Capsules and Next Day FunctioningWITHDRAWNPHASE32007-092008-012008-01
NCT00232167Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With DepressionTERMINATEDPHASE32005-112006-04
NCT00079495Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)COMPLETEDPHASE22003-072005-04
NCT00873561A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes MellitusCOMPLETEDPHASE12001-122006-072006-04