drugset / Trial / NCT03755310

Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

NCT03755310

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

EvaluationDrugModalityDoseRoute
Subject Suvorexant Small molecule 10 mg
Subject Suvorexant Small molecule 20 mg