drugset / Trial / NCT03755310
Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant
Phase 2
Unknown
43 enrolled
Diego García-Borreguero, MD, PhD
Sleep Research Institute (Paseo de la Habana 151, Madrid 28036, SPAIN) · collab
RandomizedCrossoverDouble-blindTreatment
Summary
Suvorexant improves sleep latency and wake after sleep onset in patients with primary insomnia, and is FDA approved for this condition. However, no data exist on its effects in RLS, so far. The investigators consider that suvorexant might provide a stable therapeutic efficacy for the long treatment, avoiding the risk of augmentation of symptoms commonly seen under dopamine agonists.
Timeline
- Start
- 2019-02
- Primary completion
- 2020-03
- Completion
- 2020-03
Publications
- Background 1. Sleep Med 2014;15(8):860-73. 2. Sleep Med. 2013;14(7):675-84. 3. Sleep Med 2012;13:1280-5. 4. Sleep Med 2011;12:440-4. 5. Sleep Med 2015;16(10):1252-8. 6. Sleep Med. 2016;21:1-11. 7. Sleep Med Clin 2015;10:207-14, xi. 8. Sleep Med. 2009;10(1):134-8. 9. Neurology. 2013;80(22):2028-34 10. Neurosci Biobehav Rev. 2015;49:43-54. 11. Peptides. 2014;52:29-37. 12. Curr Biol. 2013;23(18):1719-25. 13. Curr Opin Neurobiol. 2013;23(5):752-9. 14. Neurosci Bull. 2013;29(3):355-65. 15. Neurology. 2002;59(4):639-
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suvorexant | Small molecule | 10 mg | — |
| Subject | Suvorexant | Small molecule | 20 mg | — |