Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Purpose
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.
Condition
- Insomnia Disorder
Eligibility
- Eligible Ages
- Between 2 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tasimelteon |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Vanda Investigational Site
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Vanda Pharmaceuticals
Vanda Pharmaceuticals
More Details
- Status
- Recruiting
- Sponsor
- Vanda Pharmaceuticals