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Daridorexant for Pediatric Insomnia
Study Summary
This trial looks at whether a sleep drug is safe and effective for kids with insomnia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 930 Patients • NCT03545191Trial Design
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- I have been diagnosed with a sleep disorder like restless legs or narcolepsy.I have trouble sleeping at least 3 nights a week.I am between 10 and 17 years old.I have been diagnosed with chronic insomnia.I have trouble falling or staying asleep, or I wake up early and can't go back to sleep.I have had trouble sleeping for over 3 months, affecting my daily life.I have a history of sleep-related breathing disorders, but I'm still eligible if treated by tonsillectomy/adenoidectomy.I have had trouble sleeping for over 3 months, affecting my daily life.You have trouble sleeping even when you have had enough time to rest for your age.I still have trouble sleeping despite trying non-medication methods.I have had trouble sleeping for at least 3 months.My body weight is less than 25 kg.I have been napping for over an hour on most weekdays for the last 3 months.I am between 10 and 17 years old.I have given my written agreement to participate, as required.I have trouble sleeping at least 3 nights a week.I have trouble falling or staying asleep, or I wake up early and can't go back to sleep.This criterion only applies to some children who have trouble sleeping and also have another developmental condition.I have had trouble sleeping for at least 3 months.I have been diagnosed with chronic insomnia.I have given my written agreement to participate, as required.You have trouble sleeping even when you have enough time to rest for your age.You have trouble falling asleep, staying asleep, or waking up too early and not being able to go back to sleep.I have had trouble sleeping for at least 3 months.I have trouble sleeping at least 3 nights a week.
- Group 1: Placebo
- Group 2: Daridorexant 25 mg
- Group 3: Daridorexant 50 mg
- Group 4: Daridorexant 10 mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Am I eligible to enroll in this clinical research study?
"This clinical trial is scouting 150 children and adolescents, aged 10 to 17 years old, that suffer from chronic insomnia. Additionally, these patients must not be under the influence of sedatives or antidepressants; a signed consent form by their legal guardian is also mandated for participation. Moreover, participants need to report 3 nights of disturbances in sleep initiation/maintenance over at least a 3 month period and exhibit impaired daytime performance due to inadequate quality/quantity of restful slumber despite adequate bedtime scheduling and non-pharmacological treatments."
How many research centers have been granted approval to conduct this experiment in North America?
"Currently, 13 clinical sites are enrolling participants for this study; out of these locations, the closest to you could be Winter Park, Stockbridge or Little Rock. To reduce travel burden it is wise to select a clinic near your location if you decide to join in on the trial."
What is the maximum number of participants in this research endeavor?
"This trial seeks 150 participants that fulfill the set inclusionary criteria. Those interested can visit either Florida Pediatric Research Institute in Winter Park or Clinical Research Institute in Stockbridge, Georgia to take part."
What risks come with regular usage of Daridorexant 25 mg?
"The safety level of Daridorexant 25 mg has been assessed at 2 due to Phase 2 trial data confirming its general safety, but no evidence yet of efficacy."
Can individuals under 75 years old access this research endeavor?
"The age range of participants acceptable for this medical experiment are those between 10 and 17 years old."
Are there still vacancies for participants in this experiment?
"Clinicaltrials.gov confirms that this investigation is actively seeking participants--it was first announced on August 9th 2022, and recently amended as of November 15th 2022."
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