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

RecruitingPhase 3

Sponsor: Vanda Pharmaceuticals

Conditions: Insomnia Disorder

Interventions: Tasimelteon Oral Suspension, Placebo

Countries: United States, Germany, Poland, United Kingdom

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 overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (35)

Dothan, Alabama, United States
Phoenix, Arizona, United States
Irvine, California, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Winter Park, Florida, United States
Snellville, Georgia, United States
Stockbridge, Georgia, United States
Naperville, Illinois, United States
Worcester, Massachusetts, United States
Great Falls, Montana, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Cleveland, Ohio, United States
Columbia, South Carolina, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Berlin, Germany
Leipzig, Germany
Bydgoszcz, Poland
Gdansk, Poland
Krakow, Poland
Poznan, Poland
Wroclaw, Poland
Great Yarmouth, United Kingdom
Leicester, United Kingdom
+ 5 more on CT.gov