Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

Phase 3 Completed 320 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.

Timeline

Start: 2017-10-16
Primary completion: 2018-03-05
Completion: 2018-03-05

Outcome

Met primary endpoint

paper Tasimelteon treatment increased TST2/3 (primary endpoint) by 60.3 min (95%CI 44.0 to 76.7, P < 0.0001) PMID 32754110 ↗

release “Results from the JET8 study showed significant and clinically meaningful effects of HETLIOZ ® 20 mg on the primary endpoint of the study” vandapharma.com ↗

Publications

Polymeropoulos CM, Mohrman MA, Keefe MS, Brzezynski JL, Wang J, Prokosch LS, Polymeropoulos VM, Xiao C, Birznieks G, Polymeropoulos MH. Efficacy of Tasimelteon (HETLIOZ(R)) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020 Jul 9;11:611. doi: 10.3389/fneur.2020.00611. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tasimelteon	Small molecule	20 mg	Oral