Drugs / Tetrabenazine
Tetrabenazine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XENAZINE | — | 2008-08-15 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01133353 | Mar → Nov 2011 | Tourette syndrome | Bausch Health Americas, Inc. | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01543321 | May 2012 → May 2017 | tardive dyskinesia | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Phase 3 | NCT00219804 | — | Huntington disease | Prestwick Pharmaceuticals | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02509793 | Aug 2018 → Jul 2023 | Huntington disease | William Ondo, MD | Unknown | No outcome recorded |
| Phase 4 | NCT01834911 | Mar 2013 → Jan 2018 | Huntington disease | New York Medical College | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00362804 | Feb 2002 → Jan 2006 | schizoaffective disorder, schizophrenia | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00642057 | — | movement disorder | Joseph Jankovic | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00632645 Comparator | Apr 2009 → Apr 2017 | Huntington disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04523935 Comparator | Dec 2005 → Aug 2020 | cerebral palsy | Sathbhavana Brain Clinic | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tetrabenazine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00362804 ↗ |
| Known as | TBZ | “With a variety of other potential augmentation strategies available, we have chosen to focus on tetrabenazine (TBZ), which is currently licensed here in Canada for the...” NCT00362804 ↗1“Tetrabenazine (TBZ) selectively depletes central monoamines by reversibly binding to the type-2 vesicular monoamine transporter.” PMID 20021666 ↗ Dec 2009 |
| Known as | Xenazine | “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗2“Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks” NCT02509793 ↗ |
| Known as | Xenazine (tetrabenazine) | “Xenazine (tetrabenazine)” NCT01543321 ↗ |
| Action | Inhibit | “inhibitor of vesicular monoamine transporter” NCT00362804 ↗ |
| Route | Oral | “Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg” NCT00632645 ↗ |