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RecruitingPhase 3

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

Vanda Pharmaceuticals · NCT06953869

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
420
US sites recruiting
20
Study start
April 21, 2025
Record last updated
June 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Tasimelteon Oral Suspension; Placebo

Conditions: Insomnia Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 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.

Recruiting US locations

  • Vanda Investigational Site

    Dothan, AL 36303

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Phoenix, AZ 85006

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Irvine, CA 92614

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Miami, FL 33155

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Miami Lakes, FL 33016

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Winter Park, FL 32789

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Snellville, GA 30078

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Stockbridge, GA 30281

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Naperville, IL 60563

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Worcester, MA 01608

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Great Falls, MT 59405

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Las Vegas, NV 89128

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Cleveland, OH 11100

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Columbia, SC 29201

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Myrtle Beach, SC 29582

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Nashville, TN 37232

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Houston, TX 77030

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    Plano, TX 75075

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    San Antonio, TX 78229

    Site contact: Vanda Pharmaceuticals

  • Vanda Investigational Site

    San Antonio, TX 78249

    Site contact: Vanda Pharmaceuticals

Study contacts (from the official record)

  • Vanda Pharmaceuticals, Inc. · 202-734-3400 · VEC162@vandapharma.com
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Evaluating the Effects of Tasimelteon vs. Placebo in Treating… (NCT06953869) | Bored Studies