Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Condition(s) studied

Investigational drug(s) / intervention(s)

Tasimelteon Oral Suspension: Single daily dose, weight-based liquid suspension formulation.

Placebo: Placebo comparator.

Study summary

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

Eligibility

Primary outcome measure(s)

• Change in sleep latency, as measured by daily sleep diary. — 12 Weeks

Trial sites (35)