drugset / Trial / NCT04006925
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal, 2016; Moghadam, 2017).
Timeline
- Start
- 2019-09-10
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
Publications
- Background Shneerson JM. Successful treatment of REM sleep behavior disorder with sodium oxybate. Clin Neuropharmacol. 2009 May-Jun;32(3):158-9. doi: 10.1097/WNF.0b013e318193e394.
- Background Liebenthal J, Valerio J, Ruoff C, Mahowald M. A Case of Rapid Eye Movement Sleep Behavior Disorder in Parkinson Disease Treated With Sodium Oxybate. JAMA Neurol. 2016 Jan;73(1):126-7. doi: 10.1001/jamaneurol.2015.2904. No abstract available.
- Background Moghadam KK, Pizza F, Primavera A, Ferri R, Plazzi G. Sodium oxybate for idiopathic REM sleep behavior disorder: a report on two patients. Sleep Med. 2017 Apr;32:16-21. doi: 10.1016/j.sleep.2016.04.014. Epub 2016 Jun 7.
- During EH, Hernandez B, Miglis MG, Sum-Ping O, Hekmat A, Cahuas A, Ekelmans A, Yoshino F, Mignot E, Kushida CA. Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder. Sleep. 2023 Aug 14;46(8):zsad103. doi: 10.1093/sleep/zsad103.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Oxybate | Unknown | — | — |