VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

Phase 3 Completed 411 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Timeline

Start: 2006-02
Primary completion: 2006-08
Completion: 2006-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs VEC-162 20 mg; p <0.001; Mean Difference (Final Values) -21.5 (95% CI -33.1 to -9.9); ANCOVA NCT00291187 ↗

paper In the phase III study, tasimelteon improved sleep latency, sleep efficiency, and wake after sleep onset (ie, sleep maintenance). PMID 19054552 ↗

Publications

Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tasimelteon	Small molecule	20 mg	Oral
Subject	tasimelteon	Small molecule	50 mg	Oral
Subject	tasimelteon	Small molecule	100 mg	Oral