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New treatment option for Insomnia Disorder
Official title Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
ClinicalTrials.gov ID: NCT06953869
What this study is testing
What is Tasimelteon Oral Suspension?
Tasimelteon Oral Suspension is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for insomnia disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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 likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.