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

Last updated: April 23, 2025
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Anxiety Disorders

Treatment

Placebo

Tasimelteon Oral Suspension

Clinical Study ID

NCT06953869
VP-VEC-162-3108
  • Ages 2-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Ability and acceptance to provide written informed consent of the participant orlegal 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

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.

Study Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 21, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Vanda Investigational Site

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • Vanda Investigational Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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