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Clinical trials
catalyst calendar across sponsors →Studies where NBIX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
83 interventional · 3 observational · 40 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With SchizophreniaNCT07114874Number of Participants with Treatment-emergent Adverse EventsOpen-label · Treatment | Phase 3 | Recruiting | Drug: NBI-1117568 | Schizophrenia | 600 | Dec 2031 | ≤ 1,960 d | 2026-06-05 |
| Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years OldNCT07187375Plasma Concentration of CrinecerfontOpen-label · Treatment | Phase 2 | Active, not recruiting | Drug: Crinecerfont | Congenital Adrenal Hyperplasia | 7 | 2029-09-06 | in 1,114 d | 2026-06-16 |
| Efficacy of NBI-1117568 in Preventing Relapse in Adults With SchizophreniaNCT07227818Time From Randomization to RelapseRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1117568, Placebo | Schizophrenia | 560 | Jul 2029 | ≤ 1,077 d | 2026-06-05 |
| Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06966401Number of Participants with Treatment-emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 3 | Recruiting | Drug: NBI-1065845 | Major Depressive Disorder | 850 | May 2029 | ≤ 1,016 d | 2026-07-24 |
| A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT07196501Time from Randomization to RelapseRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1065845, Placebo | Major Depressive Disorder | 550 | Jul 2028 | ≤ 712 d | 2026-07-24 |
| Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in CanadaNCT06312189Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Valbenazine | Chorea, Huntington | 7 | Apr 2028 | ≤ 620 d | 2026-06-18 |
| Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years OldNCT07536269Number of Participants With Treatment-emergent Adverse Events (TEAE)Open-label · Treatment | Phase 2 | Not yet recruiting | Drug: Crinecerfont | Congenital Adrenal Hyperplasia | 20 | Mar 2028 | ≤ 590 d | 2026-04-17 |
| An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaNCT07288320Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21Randomized · Double-masked · Treatment | Phase 2 | Recruiting | Drug: NBI-1117568, Placebo | Bipolar I Disorder, Mania | 150 | Feb 2028 | ≤ 559 d | 2026-07-31 |
| NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaNCT07105098Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1117568, Placebo | Schizophrenia | 284 | Nov 2027 | ≤ 468 d | 2026-05-15 |
| NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaNCT06963034Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1117568, Placebo | Schizophrenia | 284 | Oct 2027 | ≤ 438 d | 2026-03-06 |
| Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaNCT07288333Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: NBI-1117570, Placebo | Schizophrenia | 120 | Aug 2027 | ≤ 377 d | 2026-07-22 |
| Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06786624Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1065845, Placebo | Major Depressive Disorder | 200 | Jul 2027 | ≤ 346 d | 2025-10-29 |
| NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06911112Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1065845, Placebo | Major Depressive Disorder | 200 | Jul 2027 | ≤ 346 d | 2026-08-11 |
| NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06963021Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: NBI-1065845, Placebo | Major Depressive Disorder | 200 | Jul 2027 | ≤ 346 d | 2026-08-10 |
| Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaNCT07365462Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' AssessmentRandomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: NBI-1065890, Placebo | Tardive Dyskinesia | 100 | Feb 2027 | ≤ 193 d | 2026-06-23 |
| 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) InhibitorNCT07105111Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24Open-label · Treatment | Phase 4 | Recruiting | Drug: Valbenazine | Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia | 50 | Jan 2027 | ≤ 165 d | 2026-06-16 |
| Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal HyperplasiaNCT04490915results2025-02-05Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Crinecerfont, Placebo | Congenital Adrenal Hyperplasia | 182 | 2023-07-19actual | — | 2026-05-11 |
| Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)NCT04806451results2025-02-05Change From Baseline in Serum Androstenedione at Week 4Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Crinecerfont, Placebo | Congenital Adrenal Hyperplasia | 103 | 2023-03-10actual | — | 2025-02-05 |
| Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEENCT05226780Number of Participants with Serious treatment-emergent adverse events (TEAEs), TEAEs Leading to Discontinuation and Fatal TEAEsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: This study was prematurely terminated due to sponsor decision. | Drug: NBI-921352 | SCN8A Developmental and Epileptic Encephalopathy Syndrome | 8 | 2025-11-12actual | — | 2026-05-27 |
| Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington DiseaseNCT04400331Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 3 | Completed | Drug: Valbenazine | Chorea, Huntington | 154 | 2025-11-05actual | — | 2026-06-17 |
| Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral PalsyNCT05206513Change in the Total Maximal Chorea (TMC) Score of the Unified Huntington Disease Rating Scale (UHDRS) from Baseline to the Average of the Week 12 and Week 14 assessmentsRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Valbenazine | Dyskinesia, Cerebral Palsy | 86 | 2025-10-16actual | — | 2026-04-29 |
| A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive DisorderNCT06267846Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: NBI-1070770, Placebo | Major Depressive Disorder | 73 | 2025-07-25actual | — | 2026-07-17 |
| Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for SchizophreniaNCT05110157Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 10Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Valbenazine | Schizophrenia | 442 | 2025-02-04actual | — | 2026-02-10 |
| Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepNCT05301894results2026-02-13The Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Business decision | Drug: NBI-827104 | Epileptic Encephalopathy, Continuous Spike and Wave During Sleep | 19 | 2025-01-27actual | — | 2026-02-13 |
| Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive DyskinesiaNCT05859698results2026-01-16Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Valbenazine | Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia | 59 | 2024-12-27actual | — | 2026-01-16 |
| VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)NCT03562494Number of participants with treatment-emergent adverse events (TEAEs)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Biological: VY-AADC02 · Other: Sham (Placebo) Surgery | Parkinson's Disease | 14 | 2024-10-30actual | — | 2024-12-10 |
| Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With SchizophreniaNCT05545111Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: NBI-1117568, Placebo | Schizophrenia | 210 | 2024-07-10actual | — | 2025-07-11 |
| Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With SchizophreniaNCT05182476Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite ScoreRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Failed to meet the primary endpoint | Drug: Placebo, Luvadaxistat | Schizophrenia | 216 | 2024-06-28actual | — | 2025-07-02 |
| Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset SeizuresNCT05493293The occurrence of serious treatment-emergent adverse events (TEAEs)Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint. | Drug: NBI-921352 | Focal Onset Seizure, Focal Onset Epilepsy | 82 | 2024-03-11actual | — | 2024-04-12 |
| Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)NCT05203341Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, NBI-1065845 | Major Depressive Disorder | 183 | 2024-01-10actual | — | 2025-01-15 |
| Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for SchizophreniaNCT05654870Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Study ATS3020 was closed due to business reasons. Neurocrine Biosciences will continue to conduct study ATS3019 (NCT05110157). There were no unexpected safety findings for this compound that motivated the decision. | Drug: Valbenazine, Placebo | Schizophrenia | 8 | 2023-11-08actual | — | 2024-11-12 |
| 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 SeizuresNCT05159908Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEsRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: NBI-921352, Placebo | Focal Onset Seizure, Focal Onset Epilepsy | 101 | 2023-08-21actual | — | 2024-09-26 |
| Observational, Long-term Extension Study for Participants of Prior VY-AADC01 StudiesNCT03733496observationalIncidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | — | Completed | — | Parkinson's Disease | 14 | 2023-07-18actual | — | 2023-12-22 |
| Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDDNCT05165394results2024-07-31Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Placebo, NBI-1065846 | Anhedonia, Major Depressive Disorder | 93 | 2023-07-07actual | — | 2024-07-31 |
| Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)NCT04873869results2025-10-16Percentage Change From Baseline in 28-day Seizure Frequency for Countable Motor Seizures During the 16-week Treatment PeriodRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: This study was prematurely terminated due to sponsor decision. | Drug: NBI-921352, Placebo | SCN8A Developmental and Epileptic Encephalopathy Syndrome | 8 | 2023-03-17actual | — | 2025-10-16 |
| Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepNCT04625101results2025-09-05Ratio of Spike-Wave Index (SWI) During First Hour of Nonrapid Eye Movement (NREM) Sleep at Week 6Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NBI-827104, Placebo | Epileptic Encephalopathy, Continuous Spike and Wave During Sleep | 24 | 2022-08-08actual | — | 2025-09-05 |
| Opicapone Treatment Initiation Open-Label StudyNCT04787965observationalONGENTYS treatment patterns | — | Completed | Drug: Opicapone | Parkinson Disease | 239 | 2022-08-04actual | — | 2022-11-28 |
| Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential TremorNCT04880616Change from Baseline to Day 28 of Each Treatment Period in Amplitude at Peak Frequency of Postural TremorRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: NBI-827104, Placebo | Essential Tremor | 31 | 2022-05-25actual | — | 2022-07-12 |
| Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington DiseaseNCT04102579results2023-10-11Change From Screening Period Baseline to Maintenance Period in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Valbenazine, Placebo | Chorea, Huntington | 128 | 2021-10-15actual | — | 2023-10-11 |
| Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's DiseaseNCT03065192Grading of adverse Events/Serious Adverse Events (AE's/SAE's)Open-label · Treatment | Phase 1 | Completed | Drug: VY-AADC01 | Idiopathic Parkinson's Disease, Parkinson's Disease, Basal Ganglia Disease, Brain Diseases, Central Nervous System Diseases, Movement Disorders, Nervous System Diseases, Neurodegenerative Diseases, Parkinsonian Disorders | 16 | 2021-08-10actual | — | 2022-03-21 |
| Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal HyperplasiaNCT04045145results2024-07-18Percent Change From Baseline to Day 14 in Serum 17-OHP Concentrations (Morning Window Average)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Crinecerfont | CAH - Congenital Adrenal Hyperplasia | 8 | 2021-07-02actual | — | 2024-07-18 |
| A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of SchizophreniaNCT03382639results2024-02-28Change From Baseline on the PANSS NSFS at Week 12Randomized · Double-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Luvadaxistat, Placebo | Schizophrenia | 256 | 2020-12-29actual | — | 2024-02-28 |
| A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With SchizophreniaNCT03359785results2024-02-28Change From Baseline in Average Percent of Conditioned Responses During the Eye Blink Conditioning (EBC) Test at Day 8Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Luvadaxistat, Matching Placebo | Schizophrenia | 31 | 2020-12-21actual | — | 2024-02-28 |
| Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal HyperplasiaNCT03525886results2022-05-03Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window AveragesNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NBI-74788 | CAH - Congenital Adrenal Hyperplasia | 18 | 2020-04-07actual | — | 2022-05-03 |
| A 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 ParticipantsNCT04234672results2021-04-28Period 1: Percent Absolute Bioavailability (%F) for TAK-831Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, [14C]TAK-831 Oral Suspension | Healthy Volunteers | 6 | 2020-04-04actual | — | 2021-06-30 |
| Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's DiseaseNCT01973543Safety of AADC Gene TransferNon-randomized · Single-masked · Treatment | Phase 1 | Completed | Biological: VY-AADC01 | Parkinson's Disease | 15 | 2020-01-24actual | — | 2020-03-03 |
| Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive DyskinesiaNCT03891862results2021-03-10Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Valbenazine, Placebo oral capsule | Tardive Dyskinesia (TD) | 135 | 2019-12-23actual | — | 2021-04-20 |
| Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics StudyNCT02748694results2021-03-01Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)Randomized · Double-masked · OtherStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 1 | Completed | Drug: TAK-041, TAK-041 Placebo | Healthy Volunteers, Schizophrenia | 114 | 2019-09-22actual | — | 2021-03-19 |
| 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 SchizophreniaNCT03319953results2021-02-09Change From Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 AdministrationRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TAK-041, Placebo, Second Generation Antipsychotics (SGA) | Stable Schizophrenia | 23 | 2019-09-11actual | — | 2021-03-19 |
| Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette SyndromeNCT03530293results2022-05-17Time to Loss of Treatment ResponseRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Futility | Drug: Valbenazine, Placebo oral capsule | Tourette Syndrome | 81 | 2019-07-16actual | — | 2022-05-17 |
| Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette SyndromeNCT03444038results2022-02-23Number of Participants With Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Valbenazine | Tourette Syndrome | 85 | 2019-07-12actual | — | 2022-02-23 |
| Phase 1 Study of TAK-831 in Healthy Adult Asian SubjectsNCT03687684results2020-06-29Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)Randomized · Triple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-831, Placebo | Healthy Volunteers | 40 | 2019-06-09actual | — | 2021-06-14 |
| A Study to Evaluate Central Nervous System (CNS) Pharmacodynamic Activity of TAK-653 in Healthy Participants Using Transcranial Magnetic Stimulation (TMS)NCT03792672results2020-07-02Change From Baseline in Peak-to-Peak Amplitude of Motor-evoked Potential (MEP) Obtained With Single-pulse Transcranial Magnetic Stimulation (TMS) for TAK-653 at 2.5 Hours Post TAK-653 DoseRandomized · Double-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-653, Placebo, Ketamine | Healthy Volunteers | 24 | 2019-05-15actual | — | 2021-03-19 |
| The Potential for Clinical Dependence and Withdrawal Symptoms Associated With ValbenazineNCT03698331results2020-06-04Participants With Withdrawal-Emergent Adverse EventsRandomized · Triple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 4 | Completed | Drug: Valbenazine, Placebo oral capsule | Tardive Dyskinesia (TD) | 89 | 2019-04-03actual | — | 2020-06-04 |
| Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette SyndromeNCT03732534results2022-04-19Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study stopped early due to investigational drug not meeting primary endpoint in the main study T-Force GOLD (NBI-98854-TS2003); no safety concerns identified. | Drug: NBI-98854 | Tourette Syndrome | 6 | 2019-02-18actual | — | 2022-04-19 |
| Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich AtaxiaNCT03214588results2019-12-19Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TAK-831, TAK-831 Placebo | Friedreich Ataxia | 67 | 2018-12-27actual | — | 2021-06-14 |
| A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy ParticipantsNCT03706469results2019-12-23AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831Randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-831 T2, TAK-831 T3 | Healthy Volunteers | 16 | 2018-12-11actual | — | 2021-06-14 |
| Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette SyndromeNCT03325010results2021-06-28Change From Baseline to Week 12 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Valbenazine, Placebo oral capsule | Tourette Syndrome | 127 | 2018-11-01actual | — | 2021-06-28 |
| A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy ParticipantsNCT03224325results2019-11-19Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-831 Tablet T2, Placebo, TAK-831 Suspension | Healthy | 50 | 2018-09-09actual | — | 2021-06-14 |
| Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic AgentsNCT03062033observationalCustomized clinician-reported outcomes | — | Unknown status | — | Tardive Dyskinesia | 70 | Aug 2018 | — | 2017-11-22 |
| A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.NCT03496870Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)Open-label · Treatment | Phase 1 | Completed | Drug: Opicapone, Carbidopa Levodopa | Parkinson Disease | 16 | 2018-07-02actual | — | 2019-03-22 |
| Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette SyndromeNCT02879578results2021-04-29Frequency of Treatment-emergent Adverse Events (TEAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Valbenazine | Tourette Syndrome | 155 | 2017-11-01actual | — | 2021-04-29 |
| TAK-653 Escalating Single and Multiple Dose Study in Healthy ParticipantsNCT02561156results2019-02-08Part 1: Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)Randomized · Quadruple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-653 Placebo, TAK-653 | Depressive Disorder | 88 | 2017-09-11actual | — | 2021-03-03 |
| Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive DyskinesiaNCT02736955results2018-12-19Number of Participants Monitored for Long-term Safety of ValbenazineOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Valbenazine | Tardive Dyskinesia | 161 | 2017-06-30actual | — | 2018-12-19 |
| 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)NCT02959892results2019-12-23Change in Non-displaceable Binding Potential (BP-ND) in the TAK-041+AMPH Condition Compared to AMPH AloneNon-randomized · Open-label · OtherStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 1 | Completed | Drug: Amphetamine, TAK -041, [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO) | Healthy Volunteers | 12 | 2017-05-30actual | — | 2021-03-19 |
| A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet FormulationNCT03101293results2019-03-18Cmax: Maximum Observed Plasma Concentration for TAK-831Randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: TAK-831 | Healthy Volunteers | 15 | 2017-05-19actual | — | 2021-06-14 |
| Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette SyndromeNCT02679079results2021-01-15Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NBI-98854, Placebo | Tourette Syndrome | 98 | 2017-04-14actual | — | 2021-01-15 |
| Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive DyskinesiaNCT02405091results2018-11-30Number of Participants Monitored for Long-Term Safety of ValbenazineNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: NBI-98854 | Tardive Dyskinesia | 167 | Mar 2017actual | — | 2018-11-30 |
| Safety and Efficacy Study of NBI-98854 in Adults With Tourette SyndromeNCT02581865results2020-05-07Change From Baseline to Week 8 in the YGTSS TTSRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NBI-98854, Placebo | Tourette Syndrome | 124 | Dec 2016actual | — | 2020-05-07 |
| Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral AdministrationNCT02716987results2020-08-07Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET ScanNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: TAK-831, [18F]PGM299 | Healthy | 20 | 2016-08-30actual | — | 2021-06-14 |
| A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy ParticipantsNCT02566759results2018-02-06Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)Randomized · Double-masked · Other | Phase 1 | Terminatedsponsor's stated reason: The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study. | Drug: TAK-831 Oral Suspension, TAK-831 Placebo, TAK-831 Tablet | Schizophrenia, Cerebellar Ataxia | 110 | 2016-06-09actual | — | 2021-06-14 |
| Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette SyndromeNCT02256475Number of participants with adverse events following dosing with NBI-98854Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: NBI-98854 | Tourette Syndrome | 36 | Nov 2015actual | — | 2016-01-07 |
| Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal HyperplasiaNCT02349503Number of participants with adverse events following one oral dose of NBI-77860Non-randomized · Open-label · Treatment | Phase 1 | Withdrawn | Drug: NBI-77860, NBI-77860, NBI-77860 | Congenital Adrenal Hyperplasia | 0 | Oct 2015 | — | 2015-06-11 |
| A Phase 3 Study of NBI-98854 for the Treatment of Tardive DyskinesiaNCT02274558results2017-07-11Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: NBI-98854, Placebo | Tardive Dyskinesia | 234 | Sep 2015actual | — | 2017-07-11 |
| NBI-98854 Dose Titration Study for the Treatment of Tardive DyskinesiaNCT01733121results2017-08-10Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: NBI-98854, NBI-98854, Placebo | Tardive Dyskinesia | 102 | Dec 2013actual | — | 2017-08-10 |
| Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic InsufficiencyNCT01916993Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: NBI-98854 50 mg capsule | Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects | 24 | Dec 2013actual | — | 2014-01-16 |
| NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)NCT01688037results2017-11-08Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: NBI-98854, NBI-98854, Placebo | Tardive Dyskinesia | 109 | Sep 2013actual | — | 2017-11-08 |
| Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy SubjectsNCT01910480Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 aloneOpen-label · Basic science | Phase 1 | Completed | Drug: NBI-98854 50 mg capsule once daily, Ketoconazole 400 mg (200 mg twice daily) | Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects | 24 | Aug 2013actual | — | 2013-09-05 |
| NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective DisorderNCT01393600results2017-08-10Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total ScoreRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: NBI-98854, NBI-98854, Placebo | Tardive Dyskinesia | 37 | Feb 2012actual | — | 2017-08-10 |
| Efficacy and Safety of NBI-98854 in Subjects With Tardive DyskinesiaNCT01267188Assessment of Tardive Dyskinesia symptomsNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: NBI-98854 | Tardive Dyskinesia | 10 | Mar 2011actual | — | 2011-04-20 |
| An Exploratory Study of NBI-34060 Capsules and Next Day FunctioningNCT00525941Assessments of Next-Day FunctionNon-randomized · Single-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Study discontinued due to Approvable decision | Drug: NBI-34060 | Insomnia | 0 | Jan 2008actual | — | 2015-05-12 |
| A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes MellitusNCT00873561To assess the effect of repeated administrations of NBI-6024 on endogenous insulin production as measured by C-peptide levels in adult and adolescent patients with new onset type 1 diabetes mellitusRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: NBI-6024 | Type 1 Diabetes Mellitus | 188 | Apr 2006actual | — | 2009-04-01 |
| Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast CancerNCT00039052Treatment | Phase 1 | Completed | Biological: interleukin-4 PE38KDEL cytotoxin | Breast Cancer, Kidney Cancer, Lung Cancer | — | May 2003actual | — | 2013-07-18 |
| NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma MultiformeNCT00014677Treatment | Phase 2 | Completed | Biological: interleukin-4 PE38KDEL cytotoxin · Procedure: conventional surgery | Brain and Central Nervous System Tumors | — | Sep 2002actual | — | 2013-07-18 |
| Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)NCT00079495Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: NBI-5788 | Multiple Sclerosis | 150 | — | — | 2008-03-21 |
| Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With DepressionNCT00232167Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)Randomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Please see Detailed Description below for termination reason. | Drug: Indiplon, Sertraline | Insomnia, Depression | 380 | — | — | 2007-10-02 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19