Insomnia Disorder study: Tasimelteon Oral Suspension
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?
This is an investigational liquid medicine being studied as a potential treatment for insomnia disorder in children. It is designed to mimic the effects of melatonin, a natural hormone that helps regulate the body's sleep-wake cycle.
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
- The study aims to find out if tasimelteon is safe and effective for treating insomnia in children.
- Who it's for
- The study is looking for boys and girls who have been diagnosed with insomnia disorder.
- What's involved
- Participants will take one pill by mouth every day. They will also visit the clinic for check-ups and tests.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- 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 is enrolling
- 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
- 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
- Berlin, Germany
+ 11 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, but 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?
This study is enrolling now at 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 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.