Actively Recruiting
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Led by Vanda Pharmaceuticals · Updated on 2025-05-01
420
Participants Needed
3
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Vanda Investigational Site
Winter Park, Florida, United States, 32789
Actively Recruiting
2
Vanda Investigational Site
Charlotte, North Carolina, United States, 28277
Actively Recruiting
3
Vanda Investigational Site
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
V
Vanda Pharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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