Drugs / Clobazam
Clobazam
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ONFI | — | 2011-10-21 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01291316 | Apr 2010 → Nov 2011 | neuropathy, painful | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02565108 | Jan → Jul 2016 | epilepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00162981 | Oct 2005 → Aug 2006 | generalized epilepsy | Lundbeck LLC | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT02174094 | Mar → Aug 2015 | Dravet syndrome | H. Lundbeck A/S | Withdrawn | No outcome recorded |
| Phase 3 | NCT02187809 | Mar → Oct 2015 | Dravet syndrome | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02134366 | Jul 2014 → Jul 2017 | epilepsy syndrome | The Cooper Health System | Terminated | No outcome recorded |
| Phase 3 | NCT01011036 | Dec 2009 → Apr 2010 | — | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 3 | NCT00518713 | Aug 2007 → Dec 2009 | generalized epilepsy | Lundbeck LLC | Completed | No outcome recorded |
| Phase 3 | NCT01160770 | Dec 2005 → Feb 2012 | Lennox-Gastaut syndrome | Lundbeck LLC | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03371836 | Oct 2017 → Dec 2019 | anxiety, epilepsy | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02726919 | Feb 2015 → Jun 2018 | epilepsy | Pavel Klein | Unknown | No outcome recorded |
| Phase 4 | NCT01932502 | Feb 2013 → Jun 2017 | epilepsy | St. Joseph's Hospital and Medical Center, Phoenix | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03678129 | Dec 2018 → Jun 2025 | autism spectrum disorder | King's College London | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02564952 Background | Mar 2016 → Jun 2017 | epilepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01713946 Background | Apr 2013 → Oct 2017 | tuberous sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01179828 Comparator | Jul 2010 → Apr 2015 | — | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05697614 Comparator | Mar → May 2023 | epilepsy | Dr Cipto Mangunkusumo General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clobazam | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗19“List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “Clobazam” NCT02205931 ↗ |
| Known as | Colbazam | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Frisium | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | H 4723 | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | HR 376 | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | LM 2717 | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Mystan | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | NSC-336279 | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Onfi | “clobazam (Onfi) when it replaces the pre-existing clonazepam therapy” NCT01932502 ↗ |
| Known as | Perizam | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Sympazan | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Tapclob | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Urbadan | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Known as | Urbanyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗ |
| Action | Activate | “Two agonists at the benzodiazepine-binding site of GABAA-receptors (clobazam and clonazepam) were studied using multiple experimental pain tests.” PMID 23554851 ↗ Mar 2013 |
| Modality | Small molecule | “clobazam, a 1,5-benzodiazepine, as adjunctive therapy for Lennox-Gastaut syndrome (LGS).” PMID 21956725 ↗ Sep 2011 |
| Route | Oral | “orally” NCT00162981 ↗ |