drugset / Trial / NCT02405091
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.
Timeline
- Start
- 2015-03
- Primary completion
- 2017-03
- Completion
- 2017-03
Publications
- Sajatovic M, Alexopoulos GS, Jen E, Farahmand K, Zinger C. Improvements Over Time with Valbenazine in Elderly Adults (>/=65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies. J Clin Psychiatry. 2025 Apr 23;86(2):24m15550. doi: 10.4088/JCP.24m15550.
- Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valbenazine | Small molecule | 40 mg | — |
| Subject | Valbenazine | Small molecule | 80 mg | — |