Drugs / Phenobarbital
Phenobarbital
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SEZABY | — | 2022-11-17 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00002759 | Jun 1996 → Apr 2002 | lymphoma, neutropenia, poisoning, small intestine cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03025906 | Feb 2017 → Oct 2019 | epilepsy with generalized tonic-clonic seizures | Xuanwu Hospital, Beijing | Unknown | No outcome recorded |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07548489 | Jun 2026 → Jan 2027 expected | delirium | Duke University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03650270 | Mar 2015 → Mar 2018 | epilepsy | University of Cape Town | Completed | Met primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01284556 | Nov 2010 → Jan 2013 | epilepsy | West-Ward Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT02810782 | Jun 2001 → Dec 2007 | neonatal abstinence syndrome | University of Zurich | Completed | No outcome recorded |
| Phase 3 | NCT00009620 | Feb 1993 → Feb 1995 | fetal growth restriction, intracerebral hemorrhage | NICHD Neonatal Research Network | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06081283 | Nov 2023 → Dec 2024 | brain hypoxia - ischemia, cardiac arrest, intracerebral hemorrhage, traumatic brain injury | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable6 trials | ||||||
| — | NCT03586089 | Jun 2021 → Jul 2023 | alcohol withdrawal delirium | Unity Health Toronto | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT05236166 | Apr 2017 → May 2021 | epilepsy | University Magna Graecia | Completed | No outcome recorded |
| — | NCT01224457 | May 2008 → Apr 2010 | neonatal epilepsy syndrome | Yonsei University | Completed | No outcome recorded |
| — | NCT00530413 | Mar 2007 → Mar 2009 | epilepsy | University of Toledo Health Science Campus | Withdrawn | No outcome recorded |
| — | NCT00435994 | Dec 2003 → Mar 2009 | bronchiolitis, respiratory syncytial virus infectious disease | Indiana University | Completed | No outcome recorded |
| — | NCT00381537 | — | epilepsy | Institute of Child Health | Completed | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT00734864 Background | Jun 2009 → Jun 2010 | anaplastic astrocytoma, anaplastic oligodendroglioma, gliosarcoma | Annick Desjardins | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02550028 Comparator | Sep 2015 → Jan 2017 | neonatal epilepsy syndrome | Children's Hospital of Fudan University | Terminated | No outcome recorded |
| Phase 1/2 | NCT01720667 Comparator | Mar 2013 → Oct 2017 | neonatal epilepsy syndrome | Richard H. Haas | Completed | No outcome recorded |
| Phase 2 | NCT05610085 Comparator | Mar 2023 → Jul 2027 expected | brain hypoxia - ischemia, neonatal epilepsy syndrome | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT03670160 Comparator | Oct 2018 → May 2020 | neonatal abstinence syndrome | University of Tennessee Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT05346666 Background | Jun 2022 → Sep 2023 | epilepsy | Damanhour University | Unknown | No outcome recorded |
| Phase 3 | NCT05291455 Comparator | Mar 2022 → Mar 2024 | epilepsy | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT04320940 Comparator | Mar 2021 → Feb 2023 | benign neonatal seizures | NEMA Research, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03602118 Comparator | Nov 2019 → May 2021 | neonatal epilepsy syndrome | PharPoint Research, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02726867 Comparator | Feb 2014 → Nov 2016 | epilepsy | Mid-Atlantic Epilepsy and Sleep Center, LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01958476 Comparator | Sep 2013 → Mar 2017 | neonatal abstinence syndrome | Tufts Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01713946 Background | Apr 2013 → Oct 2017 | tuberous sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT07284498 Comparator | Jan → Sep 2026 overdue | brain hypoxia - ischemia, neonatal epilepsy syndrome | Mansoura University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04156464 Comparator | Jul 2020 → Dec 2021 | alcohol withdrawal delirium | OSF Healthcare System | Unknown | No outcome recorded |
| Phase 4 | NCT03788889 Comparator | Apr 2019 | alcohol withdrawal | Santa Barbara Cottage Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT03107507 Comparator | Mar → Oct 2017 | neonatal epilepsy syndrome | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT01089504 Comparator | Sep 2010 → Nov 2014 | neonatal epilepsy syndrome | University of Rochester | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| — | NCT07098728 Comparator | Jul 2025 → Mar 2026 overdue | epilepsy | Ministry of Health and Sports, Myanmar | Recruiting | No outcome recorded |
| — | NCT07401433 Comparator | Apr 2024 → Mar 2025 | neonatal epilepsy syndrome | Hayat Abad Medical Complex, Peshawar | Completed | Missed primary |
| — | NCT03636958 Background | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
| — | NCT01175668 Comparator | Jul 2010 → Aug 2012 | neonatal abstinence syndrome | Baystate Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01184417 Comparator | Jan 2009 → Mar 2010 | alcohol withdrawal | Jonathan Rosenson | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Phenobarbital | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗35“Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide” NCT05236166 ↗ “Phenytoin/Dilantin, Fosphenytoin/Cerebyx, Phenobarbital, Primidone/Mysoline” NCT00734864 ↗ |
| Known as | Phenobarbital Sodium | “Phenobarbital Sodium Injection” NCT05610085 ↗ |
| Known as | Phenobarbital Sodium Injection | “Participants will receive either a 20-mg/kg or 40-mg/kg loading dose of Phenobarbital Sodium Injection, USP upon confirmation that the seizure was not due to metabolic imbalances.” NCT03602118 ↗ |
| Known as | Phenobarbitone | “Phenobarbitone will be administered intravenously as the first-line anticonvulsant for neonatal seizures.” NCT07401433 ↗ |
| Known as | primatene | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00435994 ↗ |
| Action | Activate | “GABAR-enhancing agent Phenobarbital” NCT00530413 ↗ |
| Route | Oral | “Patients receive oral phenobarbital, cyclosporine as in part I, and irinotecan at the MTD from part I.” NCT00002759 ↗ |