Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Recruiting
Phase 3
Interventional Study
Insomnia Disorder
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 420 (estimated)
- Sponsor
- Vanda Pharmaceuticals · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
* Confirmed clinical diagnosis of insomnia disorder
* Males and Females between 2 and 17 years, inclusive.
* The sleep disturbance must not be a result of …
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