Status:
RECRUITING
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Insomnia Disorder
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06953869
Start Date
April 21 2025
End Date
January 1 2028
Last Update
May 1 2025
Active Locations (3)
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1
Vanda Investigational Site
Winter Park, Florida, United States, 32789
2
Vanda Investigational Site
Charlotte, North Carolina, United States, 28277
3
Vanda Investigational Site
San Antonio, Texas, United States, 78229