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

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Insomnia Disorder

Treatments: Drug: Tasimelteon Oral Suspension; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06953869

VP-VEC-162-3108

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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 another medication.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 2 patient groups, including a placebo group

Tasimelteon

Experimental group

Treatment:

Drug: Tasimelteon Oral Suspension

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo