Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
ConditionInsomnia Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorVanda Pharmaceuticals
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.
Eligibility criteria
Qualifiers
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 another medication.
Disqualifiers
Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
Indication of impaired liver function.
Pregnant or lactating females.
A positive test for drugs of abuse.
Trial design
Treatments tested in this trial
- Tasimelteon Oral Suspension
- Placebo
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov