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Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
EU CTIS ID: 2024-516411-24-00
What this study is testing
To evaluate the efficacy of tasimelteon administered daily compared to placebo sleep outcomes in participants, as measured by daily diary.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A confirmed clinical diagnosis of insomnia disorder.
- Reported sleep latency on average 4 nights/week for at least 3 months prior to screening
- Sleep issues average 4 nights/week and at least 3 nights/week in each of the 4 weeks preceding randomization by sleep diary
- The sleep disturbance must not be a result of another medication.
- Male or female between 2 and 17 years of age, inclusive, at Visit 1 (V1).
- Informed consent from the legal guardian (and assent, as required).
You likely can't join if
- Use of prohibited medications (as detailed in Section 9.2.1 clinical Study Protocol).
- Previous intolerance to tasimelteon.
- Unable to dose daily with medication.
- Pregnant or breastfeeding females.
- A positive test for drugs of abuse.
- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening.
See the full eligibility criteria
- A confirmed clinical diagnosis of insomnia disorder.
- Reported sleep latency on average 4 nights/week for at least 3 months prior to screening
- Sleep issues average 4 nights/week and at least 3 nights/week in each of the 4 weeks preceding randomization by sleep diary
- The sleep disturbance must not be a result of another medication.
- Male or female between 2 and 17 years of age, inclusive, at Visit 1 (V1).
- Informed consent from the legal guardian (and assent, as required).
- Completing the required Daily Sleep Diary during screening;
- Both guardian and child are willing and able to comply with study requirements and restrictions.
- Use of prohibited medications (as detailed in Section 9.2.1 clinical Study Protocol).
- Previous intolerance to tasimelteon.
- Unable to dose daily with medication.
- Pregnant or breastfeeding females.
- A positive test for drugs of abuse.
- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening.
- Unwilling or unable to follow the medication restrictions including the washout from use of a prohibited medication.
- Any other sound medical reason as determined by the clinical investigator or the sponsor.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. 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 EU CTIS; the study team decides eligibility.