NCT06953869View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

April 21, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

January 31, 2028

Conditions
Insomnia Disorder
Interventions
DRUG

Tasimelteon Oral Suspension

Single daily dose, weight-based liquid suspension formulation.

DRUG

Placebo

Placebo comparator.

Trial Locations (3)

28277

RECRUITING

Vanda Investigational Site, Charlotte

32789

RECRUITING

Vanda Investigational Site, Winter Park

78229

RECRUITING

Vanda Investigational Site, San Antonio

Sponsors
All Listed Sponsors
lead

Vanda Pharmaceuticals

INDUSTRY