Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tasimelteon Oral Suspension

    Drug

    Single daily dose, weight-based liquid suspension formulation.

  • Placebo

    Drug

    Placebo comparator.

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: TasimelteonExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in sleep latency, as measured by daily sleep diary.

Time frame
12 Weeks

Secondary outcomes

1

Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.

Time frame
12 Weeks
2

Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.

Time frame
12 Weeks
3

Change in daytime functioning, as measured by questionnaire.

Time frame
12 Weeks
4

Change in behavior, as measured by questionnaire.

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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