Sleep Disorders

Pharmacotherapy Trials

As part of comprehensive care for patients with hypersomnia, the Cleveland Clinic Sleep Disorders Center offered clinical trials for patients with narcolepsy and idiopathic hypersomnia and investigators have contributed to numerous publications on new therapeutics for hypersomnia disorders. Highlights include:

  • TAK-861 - a novel compound under investigation for the treatment of narcolepsy that acts by targeting the orexin receptor type 2. Narcolepsy type 1 is believed to be caused by an autoimmune destruction of orexin secreting neurons in the hypothalamus.
  • Low-sodium oxybate - safety, tolerability and efficacy in patients with narcolepsy switching from sodium oxybate. Lower sodium oxybate has 92% less sodium and people with narcolepsy have an increased risk for cardiovascular disease making this an ideal form of oxybate therapy.
  • JAZZ JZP258-407 - open label study evaluating low -sodium oxybate on sleepiness, polysomnography, and functional outcomes in adults with narcolepsy or idiopathic hypersomnia. While low-sodium oxybate is approved for the treatment of narcolepsy and idiopathic hypersomnia, prior studies did not investigate multiple daytime symptoms and functional impacts or sleep architecture in these disorders.
  • Pitolisant - the first FDA approved histamine-3 receptor antagonist-inverse agonist approved for excessive daytime sleepiness and cataplexy in narcolepsy was studied in patients with idiopathic hypersomnia. This drug is currently under review by the FDA for the treatment of idiopathic hypersomnia, a chronic, debilitating central nervous system disorder with currently only one approved treatment.
  • SUVN-G3031 - randomized controlled trial studying the safety, tolerability, pharmacokinetics, and efficacy of Samelisant, a selective histamin-3 receptor inverse agonist in patients with narcolepsy with or without cataplexy.
  • TAK-994 - chemically related to TAK-861, studies of this orexin receptor 2 selective agonist investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with narcolepsy with or without cataplexy.