Recruiting

Phase 3

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

Sponsor:

Vanda Pharmaceuticals

Code:

NCT06953869

Conditions

Insomnia Disorder

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Tasimelteon Oral Suspension

Placebo

Study Details

Brief 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.

Conditions

Insomnia Disorder

Study ID

NCT06953869

Start date

Apr 21, 2025

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tasimelteon

placebo comparator: Placebo

Interventions

Tasimelteon Oral Suspension

Single daily dose, weight-based liquid suspension formulation.

Placebo

Placebo comparator.

Primary outcome measure

Change in sleep latency, as measured by daily sleep diary. [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals, Inc.

202-734-3400 VEC162@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Dothan, Alabama, United States, 36303

Vanda Investigational Site

Recruiting

Phoenix, Arizona, United States, 85006

Vanda Investigational Site

Recruiting

Irvine, California, United States, 92614

Vanda Investigational Site

Recruiting

Miami, Florida, United States, 33155

Vanda Investigational Site

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Miami Lakes, Florida, United States, 33016

Vanda Investigational Site

Recruiting

Winter Park, Florida, United States, 32789

Vanda Investigational Site

Recruiting

Snellville, Georgia, United States, 30078

Vanda Investigational Site

Recruiting

Stockbridge, Georgia, United States, 30281

Vanda Investigational Site

Recruiting

Naperville, Illinois, United States, 60563

Vanda Investigational Site

Recruiting

Worcester, Massachusetts, United States, 01608

Vanda Investigational Site

Recruiting

Great Falls, Montana, United States, 59405

Vanda Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89128

Vanda Investigational Site

Recruiting

Cleveland, Ohio, United States, 11100

Vanda Investigational Site

Recruiting

Columbia, South Carolina, United States, 29201

Vanda Investigational Site

Recruiting

Myrtle Beach, South Carolina, United States, 29582

Vanda Investigational Site

Recruiting

Nashville, Tennessee, United States, 37232

Vanda Investigational Site

Recruiting

Houston, Texas, United States, 77030

Vanda Investigational Site

Recruiting

Plano, Texas, United States, 75075

Vanda Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Vanda Investigational Site

Recruiting

San Antonio, Texas, United States, 78249

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2026-06-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.