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Clinical trials
catalyst calendar across sponsors →Studies where SUPN 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.
58 interventional · 3 observational · 3 expanded access · 37 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant EpilepsyNCT05518578Effects of SPN-817 on safety and tolerabilityOpen-label · Treatment | Phase 2 | Recruiting | Drug: SPN-817 | Epilepsy, Seizures, Epileptic | 60 | 2027-12-31 | in 499 d | 2026-04-21 |
| SPN-817 Open-Label Extension Study in Adults With Focal Onset SeizuresNCT07141329Incidence of treatment-emergent adverse eventsOpen-label · Treatment | Phase 2 | Recruiting | Drug: SPN-817 | Focal Onset Seizures | 100 | 2027-12-31 | in 499 d | 2025-10-10 |
| RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset SeizuresNCT06798896Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance PeriodRandomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: SPN-817, Placebo | Focal Onset Seizures | 216 | Aug 2027 | ≤ 377 d | 2026-06-01 |
| Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:NCT07219927observationalTitration Duration and Time to Optimized Dose | — | Recruiting | Other: Observational study | Parkinson Disease | 120 | 2027-08-01 | in 347 d | 2025-10-22 |
| Double-blind, Placebo-controlled Study in Adults With Major Depressive DisorderNCT07226661Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.Randomized · Triple-masked · Treatment | Phase 2 | Recruiting | Drug: SPN-821 2400 mg, Placebo | Major Depressive Disorder (MDD) | 230 | 2026-12-31 | in 134 d | 2026-03-24 |
| BIS-001-ER for the Treatment of Adult Focal Impaired Awareness SeizuresNCT03474770Effect of BIS-001ER on Seizure CountOpen-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: BIS-001ER | Focal Impaired Awareness Seizures | 16 | 2026-12-30 | in 133 d | 2022-08-30 |
| Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)NCT02736656Incidence of adverse eventsOpen-label · Treatment | Phase 3 | Active, not recruiting | Drug: SPN-812 | Attention-Deficit/Hyperactivity Disorder | 1,400 | Sep 2026 | ≤ 42 d | 2026-07-15 |
| Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHDNCT04781140Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6)Randomized · Quadruple-masked · Treatment | Phase 4 | Recruiting | Drug: 100mg SPN-812, Placebo | Attention-Deficit/Hyperactivity Disorder | 286 | Jun 2026 | — | 2026-02-18 |
| A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's DiseaseNCT05655520results2025-12-17Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Internal company decision | Drug: SAGE-718 | Huntington's Disease | 153 | 2025-01-20actual | — | 2025-12-17 |
| Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood SymptomsNCT06185985results2026-03-06Change From Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score by Visit.Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: SPN-812 | Attention-Deficit/Hyperactivity Disorder | 161 | 2024-12-03actual | — | 2026-03-27 |
| A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)NCT05107128results2025-09-05Change From Baseline in the SDMTRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-718, Placebo | Huntington's Disease | 189 | 2024-09-04actual | — | 2025-09-15 |
| A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)NCT05619692results2025-06-18Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-718, SAGE-718-matching Placebo | Mild Cognitive Impairment, Mild Dementia, Alzheimer's Disease | 174 | 2024-06-05actual | — | 2025-09-15 |
| 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's DiseaseNCT05358821results2025-05-06Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at BaselineRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-718, Placebo | Huntington Disease | 69 | 2024-02-29actual | — | 2025-09-15 |
| A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive ImpairmentNCT05318937results2025-02-06Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-718-matching placebo, SAGE-718 | Parkinson Disease, Cognitive Dysfunction | 86 | 2024-01-17actual | — | 2025-09-12 |
| An Open-Label Study Evaluating Brexanolone in Adults With TinnitusNCT05645432results2024-12-12Number of Participants With Treatment-Emergent Adverse Events (TEAE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Brexanolone | Tinnitus | 10 | 2023-11-21actual | — | 2025-09-15 |
| Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating WomenNCT06259331results2024-06-06AUCtau,MilkOpen-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: SPN-812 (600mg, QD) | Healthy Lactating Women | 15 | 2023-09-20actual | — | 2024-06-06 |
| Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHDNCT04786990results2024-05-01Incidence of Adverse Events During 8 Weeks of Adjunct SPN-812 TreatmentOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: SPN-812 | Attention-Deficit/Hyperactivity Disorder (ADHD) | 96 | 2023-05-23actual | — | 2024-05-01 |
| Therapy for Migraine Prevention in Children 6-11 Years of AgeNCT04050293results2025-11-21Change From Baseline in Monthly Migraine Days (MMDs) in Children 6 to 11 Years Old With Migraine.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Terminatedsponsor's stated reason: Difficulty in recruitment | Drug: SPN-538, Placebo | Migraine Disorders, Headache Disorders | 26 | 2023-03-01actual | — | 2026-01-22 |
| Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHDNCT04143217results2024-02-13Incidence of Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SPN-812 | Attention-Deficit/Hyperactivity Disorder | 159 | 2022-07-26actual | — | 2024-02-13 |
| A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home SettingNCT05059600results2023-07-19Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/DiscontinuationOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: ZULRESSO® | Postpartum Depression | 52 | 2022-07-14actual | — | 2025-09-15 |
| A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)NCT04476017results2023-06-06Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-718 | Parkinson Disease, Cognitive Dysfunction | 18 | 2022-03-25actual | — | 2025-09-15 |
| Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult SubjectsNCT05102552Relative BioavailabilityRandomized · Open-label · Other | Early Phase 1 | Completed | Drug: SPN-817, Treatment B, SPN-817, Treatment C, BIS-001, Treatment A | Healthy Volunteer | 30 | 2022-03-25actual | — | 2022-08-30 |
| Mass Balance Study of NV-5138 in Healthy Male SubjectsNCT05384977Cumulative total radioactivity in urine and faecesOpen-label · Treatment | Phase 1 | Completed | Drug: [14C]-NV-5138 | Healthy Volunteers | 6 | 2021-12-09actual | — | 2022-05-23 |
| Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy ParticipantsNCT05049343Change in Electrophysiological Parameter: Auditory Evoked Potential (AEP) in a Single-stimulus Paradigm Before and After Ketamine Infusion in Participants Receiving SAGE-904 Versus (vs) Participants Receiving PlaceboRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: SAGE-904, Placebo, Ketamine | Healthy Volunteer | 22 | 2021-11-20actual | — | 2025-09-17 |
| 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)NCT04602624results2024-10-10Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-718 | Alzheimer Disease, Cognitive Dysfunction, Mild Dementia | 26 | 2021-09-28actual | — | 2025-09-15 |
| Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)NCT02691182results2024-05-16Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total ScoreOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The program was shut down due to a lack of efficacy. | Drug: SPN-810 | Attention Deficit Hyperactivity Disorder (ADHD) | 491 | May 2021actual | — | 2024-05-16 |
| A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)NCT03665038results2022-08-11Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Brexanolone | Post Partum Depression | 28 | 2021-01-08actual | — | 2025-09-15 |
| Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHDNCT04016779results2022-07-12Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, SPN-812 | Attention-Deficit/Hyperactivity Disorder (ADHD) | 374 | 2020-10-10actual | — | 2022-07-12 |
| Classroom Study of SPN-812 in Children With ADHDNCT04016792Efficacy of SPN-812 assessed by Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale- Combined Score (SKAMP-CS)Randomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Study stopped before enrollment due to non-safety related corporate decision. | Drug: Placebo, 200 mg SPN-812 | ADHD | 0 | Sep 2020 | — | 2019-09-18 |
| Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD TreatmentNCT03597503results2024-02-20Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression DiaryRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Business decision, not related to safety | Drug: SPN-810, Placebo | Attention Deficit Hyperactivity Disorder | 41 | 2020-01-22actual | — | 2024-04-24 |
| Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)NCT03944785results2021-02-18observationalChange From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Drug: XADAGO (safinamide) | Idiopathic Parkinson Disease | 164 | 2019-12-23actual | — | 2023-06-07 |
| Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)NCT02618434results2024-03-18Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression DiaryRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SPN-810 (18 mg), SPN-810 (36 mg), Placebo | Attention Deficit Hyperactivity Disorder (ADHD) | 297 | 2019-11-15actual | — | 2024-03-18 |
| Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHDNCT03638466results2025-05-02Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP TaskRandomized · Quadruple-masked · Basic scienceStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Financial decision | Diagnostic test: Functional Magnetic Resonance Imaging (fMRI), Magnetic Resonance Spectroscopy (MRS) · Behavioral: Point Subtraction Aggression Paradigm (PSAP) Task · Drug: SPN-810, Placebo | Attention Deficit Hyperactivity Disorder (ADHD), Impulsive Aggression | 7 | 2019-11-07actual | — | 2025-05-02 |
| A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part BNCT03787758Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.Open-label · Treatment | Phase 1 | Completed | Drug: SAGE-718 | Huntington Disease | 6 | 2019-10-07actual | — | 2025-09-17 |
| Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)NCT02618408results2022-11-01Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression DiaryRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SPN-810 (18 mg), SPN-810 (36 mg), Placebo | Attention Deficit Hyperactivity Disorder (ADHD) | 333 | 2019-09-04actual | — | 2024-01-02 |
| A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy SubjectsNCT03844906Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs PlaceboRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: SAGE-718, Placebo | Healthy Volunteer | 40 | 2019-03-18actual | — | 2025-09-17 |
| Functional MRI Study in Healthy Children Engaged in Aggressive BehaviorsNCT03615703observationalBrain Imaging in typically developing healthy children during the PSAP aggression Task | — | Completed | — | Impulsive Aggression | 17 | 2019-03-15actual | — | 2019-06-10 |
| 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 SubjectsNCT03770780Change in glutamate and glutamine (GLX) in the anterior cingulate cortex (ACC), hippocampus, and pons as measured with magnetic resonance spectroscopy (MRS)Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: SAGE-718, Placebo | Healthy Volunteer | 19 | 2019-03-08actual | — | 2025-09-17 |
| Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHDNCT03247556results2021-07-02Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, 400mg SPN-812, 600mg SPN-812 | ADHD | 297 | 2019-02-14actual | — | 2021-07-02 |
| A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy SubjectsNCT03771586Change in the electrophysiological parameters, auditory evoked potentials, between pre- and post-ketamine infusion in subjects receiving SAGE-718 vs the change in parameters between pre- and post-ketamine infusion in subjects receiving placeboRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: SAGE-718, Placebo | Healthy Volunteer | 22 | 2018-12-17actual | — | 2025-09-17 |
| Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHDNCT03247517results2021-06-18Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, 200mg SPN-812, 400mg SPN-812 | ADHD | 310 | 2018-10-17actual | — | 2021-06-18 |
| Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHDNCT03247543results2021-07-08Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, 200mg SPN-812, 400mg SPN-812 | ADHD | 313 | 2018-10-17actual | — | 2021-07-08 |
| Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHDNCT03247530results2021-06-02Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, 100mg SPN-812, 200mg SPN-812 | ADHD | 477 | 2018-09-12actual | — | 2021-07-02 |
| Bioavailability, Safety, and Tolerability of BIS-001 ERNCT03156439Maximum serum concentration; CmaxOpen-label · Treatment | Phase 1 | Completed | Drug: BIS-001 ER | Epilepsy, Complex Partial | 8 | 2017-09-30actual | — | 2018-01-18 |
| A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)NCT02942004results2019-06-13Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h | Postpartum Depression | 138 | 2017-09-24actual | — | 2025-10-14 |
| A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)NCT02942017results2019-06-13Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Placebo, SAGE-547 90 μg/kg/h | Postpartum Depression | 108 | 2017-09-17actual | — | 2025-09-15 |
| A Study With SAGE-547 for Super-Refractory Status EpilepticusNCT02477618results2019-05-02Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo InfusionRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-547, Placebo | Super-Refractory Status Epilepticus | 132 | 2017-07-18actual | — | 2025-10-14 |
| Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHDNCT02633527results2021-10-27The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, 100mg SPN-812, 200mg SPN-812, 300mg SPN-812, 400mg SPN-812 | Attention-Deficit/Hyperactivity Disorder (ADHD) | 222 | 2016-07-25actual | — | 2021-10-27 |
| A Study to Evaluate SAGE-547 in Participants With Severe Postpartum DepressionNCT02614547results2021-09-13Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total ScoreRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: SAGE-547, Placebo | Severe Postpartum Depression | 21 | 2016-06-22actual | — | 2025-09-15 |
| Evaluate SAGE-547 in Female Participants With Severe Postpartum DepressionNCT02285504results2021-12-02Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Open-label · Treatment | Phase 2 | Completed | Drug: SAGE-547 | Postpartum Depression | 4 | 2015-06-05actual | — | 2025-09-15 |
| Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status EpilepticusNCT02052739results2022-05-03Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: SAGE-547 | Super-refractory Status Epilepticus | 25 | 2015-05-03actual | — | 2025-09-15 |
| Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810MNCT02023606Urinary and fecal recoveries (mass balance) of total radioactivity.Open-label · Treatment | Phase 1 | Completed | Drug: SPN-810M | Impulsive Aggression Comorbid With ADHD | 7 | Dec 2013actual | — | 2016-05-13 |
| Open-Label, Extension Study to 810P202NCT01416064Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHDOpen-label · Treatment | Phase 2 | Completed | Drug: Molindone | Impulsive Aggression Comorbid With ADHD in Children | 78 | Jan 2013actual | — | 2017-05-02 |
| 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)NCT01364662Reduction in aggressive behavior as assessed by R-MOAS scoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: SPN-810, Placebo | Impulsive Aggression Comorbid With ADHD | 121 | Oct 2012actual | — | 2021-02-11 |
| Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With EpilepsyNCT01284530steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerabilityRandomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: TPM XR | Epilepsy | 30 | Jun 2012actual | — | 2016-06-02 |
| Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial EpilepsyNCT00908349results2017-05-31Percent Change in Seizure RateOpen-label · Treatment | Phase 3 | Completed | Drug: Oxcarbazepine XR | Partial Epilepsy | 214 | Nov 2011actual | — | 2017-05-31 |
| Evaluation of Immediate-Release Viloxazine in Adults With ADHDNCT01107496results2024-10-15Incidence of Adverse Events During 6 Weeks of TreatmentRandomized · Quadruple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: IR Viloxazine, Placebo | Attention-Deficit/Hyperactivity Disorder (ADHD) | 52 | Dec 2010actual | — | 2024-10-15 |
| A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)NCT01114854relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasmaOpen-label · Treatment | Phase 1 | Completed | Drug: Topiramate IR, Topiramate ER | Epilepsy | 69 | Dec 2010actual | — | 2017-05-18 |
| Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy PatientsNCT00918047Examine the steady-state pharmacokinetics (PK) of OXC XR and to assess the safety and tolerability of repeated oral dosing of OXC XR in pediatric subjects with partial seizures.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: SPN-804O | Epilepsies, Partial | 18 | Jul 2010actual | — | 2017-07-02 |
| Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial SeizuresNCT00772603results2014-02-11PCH(T), ITTRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, 2400mg SPN-804, 1200mg SPN-804 | Epilepsies, Partial | 366 | Apr 2010actual | — | 2014-02-11 |
| Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct ProblemsNCT00626236results2025-09-16The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale ScoreRandomized · Open-label · TreatmentStatistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SPN-810, SPN-810, SPN-810, SPN-810 | Attention Deficit Disorder With Hyperactivity, Conduct Disorder | 78 | 2009-09-23actual | — | 2025-12-09 |
| Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy SubjectsNCT00918424expanded access | — | Approved for marketing | Drug: Oxcarbazepine Extended Release | Epilepsy | — | — | — | 2017-05-09 |
| An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status EpilepticusNCT02433314expanded access | — | No longer available | Drug: SAGE-547 | Super-Refractory Status Epilepticus | — | — | — | 2025-09-15 |
| Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum DepressionNCT03924492expanded access | — | Approved for marketing | Drug: ZULRESSO (brexanolone) injection | Postpartum Depression | — | — | — | 2025-09-15 |
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