Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Start Date
4/21/2025
Completion Date
1/1/2028
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
Age Range: 2 years to 17 years
Interventions
Tasimelteon Oral Suspension
Placebo
Conditions
Locations
Vanda Investigational Site
Dothan, Alabama 36303
United States
Vanda Investigational Site
Phoenix, Arizona 85006
United States
Vanda Investigational Site
Irvine, California 92614
United States
Vanda Investigational Site
Miami, Florida 33155
United States
Vanda Investigational Site
Miami Lakes, Florida 33016
United States
Vanda Investigational Site
Winter Park, Florida 32789
United States
Vanda Investigational Site
Snellville, Georgia 30078
United States
Vanda Investigational Site
Stockbridge, Georgia 30281
United States
Vanda Investigational Site
Naperville, Illinois 60563
United States
Vanda Investigational Site
Worcester, Massachusetts 01608
United States
Vanda Investigational Site
Great Falls, Montana 59405
United States
Vanda Investigational Site
Lincoln, Nebraska 68526
United States
Vanda Investigational Site
Las Vegas, Nevada 89128
United States
Vanda Investigational Site
Cleveland, Ohio 11100
United States
Vanda Investigational Site
Columbia, South Carolina 29201
United States
Vanda Investigational Site
Myrtle Beach, South Carolina 29582
United States
Vanda Investigational Site
Nashville, Tennessee 37232
United States
Vanda Investigational Site
Houston, Texas 77030
United States
Vanda Investigational Site
Plano, Texas 75075
United States
Vanda Investigational Site
San Antonio, Texas 78229
United States
Vanda Investigational Site
San Antonio, Texas 78249
United States
Vanda Investigational Site
Berlin, 10117
Germany
Vanda Investigational Site
Leipzig, 04177
Germany
Vanda Investigational Site
Bydgoszcz, 85-092
Poland
Vanda Investigational Site
Gdansk, 80-546
Poland
Vanda Investigational Site
Krakow, 30-721
Poland
Vanda Investigational Site
Poznan, 60-848
Poland
Vanda Investigational Site
Wroclaw, 50-414
Poland
Vanda Investigational Site
Great Yarmouth, NR31 6LA
United Kingdom
Vanda Investigational Site
Leicester, LE1 5WW
United Kingdom
Vanda Investigational Site
Liverpool, L12 2AP
United Kingdom
Vanda Investigational Site
London, E1 1FR
United Kingdom
Vanda Investigational Site
London, SE1 7EH
United Kingdom
Vanda Investigational Site
London, SE6 4LF
United Kingdom
Vanda Investigational Site
Sheffield, S10 2TH
United Kingdom