Indivior Pharmaceuticals, Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-01-19: Study NCT07226661; Company role Lead sponsor; Phase Phase 2; Status Recruiting.
- 2025-07-30: Study NCT07141329; Company role Lead sponsor; Phase Phase 2; Status Recruiting.
- 2025-03-31: Study NCT07219927; Company role Lead sponsor; Phase Observational; Status Recruiting.
- 2024-12-30: Study NCT06798896; Company role Lead sponsor; Phase Phase 2; Status Recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-01-19 | NCT07226661 Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder | Lead sponsor | Phase 2 | Recruiting | Major Depressive Disorder (MDD) | 230 | 2027-01-31 |
| 2025-07-30 | NCT07141329 SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures | Lead sponsor | Phase 2 | Recruiting | Focal Onset Seizures | 100 | 2027-12-31 |
| 2025-03-31 | NCT07219927 Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: | Lead sponsor | Observational | Recruiting | Parkinson Disease | 120 | 2027-08-01 |
| 2024-12-30 | NCT06798896 RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures | Lead sponsor | Phase 2 | Recruiting | Focal Onset Seizures | 216 | 2027-08 |
| 2024-03-25 | NCT06185985 Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms | Lead sponsor | Phase 4 | Completed Results posted | Attention-Deficit/Hyperactivity Disorder | 161 | 2024-12-11 |
| 2024-03-19 | NCT04781140 Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD | Lead sponsor | Phase 4 | Recruiting | Attention-Deficit/Hyperactivity Disorder | 286 | 2028-01 |
| 2024-02-15 | NCT06235905 Open-Label of SPN-820 in Adults With Major Depressive Disorder | Collaborator Lead: Navitor Pharmaceuticals, Inc. | Phase 2 | Completed Results posted | Major Depressive Disorder | 40 | 2024-08-18 |
| 2023-05-23 | NCT06259331 Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women | Lead sponsor | Phase 4 | Completed Results posted | Healthy Lactating Women | 15 | 2023-09-20 |
| 2023-05-10 | NCT05645432 An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus | Lead sponsor | Phase 2 | Completed Results posted | Tinnitus | 10 | 2023-11-21 |
| 2023-02-07 | NCT05518578 Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy | Lead sponsor | Phase 2 | Recruiting | Epilepsy; Seizures, Epileptic | 60 | 2027-12-31 |
| 2022-12-14 | NCT05655520 A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease | Lead sponsor | Phase 3 | Terminated Results posted | Huntington's Disease | 153 | 2025-01-20 |
| 2022-11-29 | NCT05619692 A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD) | Lead sponsor | Phase 2 | Completed Results posted | Mild Cognitive Impairment; Mild Dementia; Alzheimer's Disease | 174 | 2024-07-09 |
| 2022-06-06 | NCT05318937 A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment | Lead sponsor | Phase 2 | Completed Results posted | Parkinson Disease; Cognitive Dysfunction | 86 | 2024-02-23 |
| 2022-05-26 | NCT05358821 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease | Lead sponsor | Phase 2 | Completed Results posted | Huntington Disease | 69 | 2024-04-10 |
| 2022-01-26 | NCT05107128 A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD) | Lead sponsor | Phase 2 | Completed Results posted | Huntington's Disease | 189 | 2024-10-03 |
| 2022-01-18 | NCT05066672 Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression | Collaborator Lead: Navitor Pharmaceuticals, Inc. | Phase 2 | Completed Results posted | Treatment Resistant Depression | 250 | 2025-01-21 |
| 2021-11-11 | NCT05384977 Mass Balance Study of NV-5138 in Healthy Male Subjects | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 6 | 2021-12-09 |
| 2021-11-11 | NCT05152680 Mass Balance Study of NV-5138 in Healthy Male Subjects. | Collaborator Lead: Navitor Pharmaceuticals, Inc. | Phase 1 | Completed | Healthy Volunteers | 6 | 2021-12-09 |
| 2021-10-19 | NCT05102552 Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects | Lead sponsor | Early Phase 1 | Completed | Healthy Volunteer | 30 | 2022-08-15 |
| 2021-10-08 | NCT05059600 A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting | Lead sponsor | Phase 4 | Completed Results posted | Postpartum Depression | 52 | 2022-07-14 |
| 2021-09-21 | NCT05049343 Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 22 | 2021-12-03 |
| 2021-07-27 | NCT04786990 Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD | Lead sponsor | Phase 4 | Completed Results posted | Attention-Deficit/Hyperactivity Disorder (ADHD) | 96 | 2023-07-26 |
| 2020-12-07 | NCT04602624 A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD) | Lead sponsor | Phase 2 | Completed Results posted | Alzheimer Disease; Cognitive Dysfunction; Mild Dementia | 26 | 2021-09-28 |
| 2020-07-31 | NCT04476017 A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI) | Lead sponsor | Phase 2 | Completed Results posted | Parkinson Disease; Cognitive Dysfunction | 18 | 2022-03-25 |
| 2020-07-14 | NCT04050293 Therapy for Migraine Prevention in Children 6-11 Years of Age | Lead sponsor | Phase 4 | Terminated Results posted | Migraine Disorders; Headache Disorders | 26 | 2023-03-01 |
| 2020-01-23 | NCT04143217 Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD | Lead sponsor | Phase 3 | Completed Results posted | Attention-Deficit/Hyperactivity Disorder | 159 | 2022-12-14 |
| 2019-11-20 | NCT04016779 Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD | Lead sponsor | Phase 3 | Completed Results posted | Attention-Deficit/Hyperactivity Disorder (ADHD) | 374 | 2020-10-10 |
| 2019-08 | NCT04016792 Classroom Study of SPN-812 in Children With ADHD | Lead sponsor | Phase 3 | Withdrawn | ADHD | 0 | 2020-11 |
| 2019-05-30 | NCT03638466 Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD | Lead sponsor | Phase 2 | Terminated Results posted | Attention Deficit Hyperactivity Disorder (ADHD); Impulsive Aggression | 7 | 2019-11-07 |
| 2019-02-28 | NCT03787758 A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B | Lead sponsor | Phase 1 | Completed | Huntington Disease | 6 | 2019-10-07 |
| 2018-12-27 | NCT03844906 A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 40 | 2019-04-01 |
| 2018-11-12 | NCT03770780 A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 19 | 2019-03-22 |
| 2018-09-24 | NCT03771586 A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 22 | 2019-01-02 |
| 2018-09-07 | NCT03665038 A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) | Lead sponsor | Phase 3 | Completed Results posted | Post Partum Depression | 28 | 2021-01-08 |
| 2018-08-10 | NCT03615703 Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors | Lead sponsor | Observational | Completed | Impulsive Aggression | 17 | 2019-03-15 |
| 2018-07-31 | NCT03597503 Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment | Lead sponsor | Phase 3 | Terminated Results posted | Attention Deficit Hyperactivity Disorder | 41 | 2020-01-22 |
| 2018-04-10 | NCT03474770 BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures | Lead sponsor | Phase 1, Phase 2 | Active not recruiting | Focal Impaired Awareness Seizures | 16 | 2026-12-30 |
| 2017-11-30 | NCT03944785 Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide) | Lead sponsor | Observational | Completed Results posted | Idiopathic Parkinson Disease | 164 | 2020-01-10 |
| 2017-11-20 | NCT03247556 Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD | Lead sponsor | Phase 3 | Completed Results posted | ADHD | 297 | 2019-02-14 |
| 2017-11-02 | NCT03247517 Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD | Lead sponsor | Phase 3 | Completed Results posted | ADHD | 310 | 2018-10-17 |
| 2017-10-31 | NCT03247543 Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHD | Lead sponsor | Phase 3 | Completed Results posted | ADHD | 313 | 2018-10-17 |
| 2017-10-30 | NCT03280342 Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine | Collaborator Lead: University of Minnesota | Phase 2 | Withdrawn | Migraine; Headache | 0 | 2018-09-13 |
| 2017-10-20 | NCT03247530 Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD | Lead sponsor | Phase 3 | Completed Results posted | ADHD | 477 | 2018-09-12 |
| 2017-05-22 | NCT03156439 Bioavailability, Safety, and Tolerability of BIS-001 ER | Lead sponsor | Phase 1 | Completed | Epilepsy, Complex Partial | 8 | 2017-09-30 |
| 2016-08-01 | NCT02942004 A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) | Lead sponsor | Phase 3 | Completed Results posted | Postpartum Depression | 138 | 2017-10-19 |
| 2016-07 | NCT02942017 A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) | Lead sponsor | Phase 3 | Completed Results posted | Postpartum Depression | 108 | 2017-10-11 |
| 2016-04 | NCT02691182 Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) | Lead sponsor | Phase 3 | Terminated Results posted | Attention Deficit Hyperactivity Disorder (ADHD) | 491 | 2021-05 |
| 2016-02-16 | NCT02618434 Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) | Lead sponsor | Phase 3 | Completed Results posted | Attention Deficit Hyperactivity Disorder (ADHD) | 297 | 2020-02-14 |
| 2016-02-02 | NCT02736656 Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) | Lead sponsor | Phase 3 | Active not recruiting | Attention-Deficit/Hyperactivity Disorder | 1,400 | 2026-09 |
| 2016-02-01 | NCT02633527 Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD | Lead sponsor | Phase 2 | Completed Results posted | Attention-Deficit/Hyperactivity Disorder (ADHD) | 222 | 2016-07-25 |
| 2016-01-25 | NCT02618408 Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) | Lead sponsor | Phase 3 | Completed Results posted | Attention Deficit Hyperactivity Disorder (ADHD) | 333 | 2019-10-24 |
| 2015-12-15 | NCT02614547 A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression | Lead sponsor | Phase 2 | Completed Results posted | Severe Postpartum Depression | 21 | 2016-06-22 |
| 2015-06 | NCT02477618 A Study With SAGE-547 for Super-Refractory Status Epilepticus | Lead sponsor | Phase 3 | Completed Results posted | Super-Refractory Status Epilepticus | 132 | 2017-08-11 |
| 2015-01-07 | NCT02285504 Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression | Lead sponsor | Phase 2 | Completed Results posted | Postpartum Depression | 4 | 2015-06-05 |
| 2014-03-21 | NCT02052739 Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Super-refractory Status Epilepticus | 25 | 2015-05-03 |
| 2013-11 | NCT02023606 Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M | Lead sponsor | Phase 1 | Completed | Impulsive Aggression Comorbid With ADHD | 7 | 2013-12 |
| 2011-09 | NCT01416064 Open-Label, Extension Study to 810P202 | Lead sponsor | Phase 2 | Completed | Impulsive Aggression Comorbid With ADHD in Children | 78 | 2013-02 |
| 2011-06 | NCT01364662 A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD) | Lead sponsor | Phase 2 | Completed | Impulsive Aggression Comorbid With ADHD | 121 | 2012-10 |
| 2011-01 | NCT01284530 Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy | Lead sponsor | Phase 1, Phase 2 | Completed | Epilepsy | 30 | 2012-06 |
| 2010-06 | NCT01114854 A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM) | Lead sponsor | Phase 1 | Completed | Epilepsy | 69 | 2011-01 |
| 2010-06 | NCT01107496 Evaluation of Immediate-Release Viloxazine in Adults With ADHD | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Attention-Deficit/Hyperactivity Disorder (ADHD) | 52 | 2010-12 |
| 2010-01 | NCT01085461 Assessment of Suicidality in Epilepsy - Rating Tools | Collaborator Lead: The Epilepsy Study Consortium | Observational | Completed | Epilepsy | 200 | 2011-12 |
| 2009-06 | NCT00918424 Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects | Lead sponsor | Expanded_access | Approved for marketing | Epilepsy | ||
| 2009-06 | NCT00918047 Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients | Lead sponsor | Phase 1 | Completed | Epilepsies, Partial | 18 | 2010-11 |
| 2009-06 | NCT00908349 Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy | Lead sponsor | Phase 3 | Completed Results posted | Partial Epilepsy | 214 | 2011-11 |
| 2008-11 | NCT01246765 National Pregnancy Registry for Psychiatric Medications | Collaborator Lead: Massachusetts General Hospital | Observational | Recruiting | Pregnant Women; Psychotropic Drugs | 5,000 | 2033-12 |
| 2008-11 | NCT00772603 Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures | Lead sponsor | Phase 3 | Completed Results posted | Epilepsies, Partial | 366 | 2010-11 |
| 2008-10-21 | NCT00626236 Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems | Lead sponsor | Phase 2 | Completed Results posted | Attention Deficit Disorder With Hyperactivity; Conduct Disorder | 78 | 2009-09-23 |
| NCT03924492 Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression | Lead sponsor | Expanded_access | Approved for marketing | Postpartum Depression | |||
| NCT02433314 An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus | Lead sponsor | Expanded_access | No longer available | Super-Refractory Status Epilepticus |
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