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Orexin Antagonist

Daridorexant for Pediatric Insomnia

Phase 2
Recruiting
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged ≥ 10 and < 18 years at the time of signing the ICF
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days).
Awards & highlights

Study Summary

This trial looks at whether a sleep drug is safe and effective for kids with insomnia.

Who is the study for?
This trial is for children and teenagers aged 10 to less than 18 years with chronic insomnia, which means they've had trouble sleeping for at least three months. They should have difficulty sleeping at least three nights a week despite good sleep opportunities. The study excludes those under 25 kg, who nap a lot during the day, or have other sleep disorders or significant medical conditions.Check my eligibility
What is being tested?
The trial is testing different doses of Daridorexant (10 mg, 25 mg, and 50 mg) against a placebo to see how well it works and its safety in young people with insomnia. Participants will take the medication orally over multiple doses to assess its effects on their sleep issues.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with sleep medications may include dizziness, headache, nausea, daytime drowsiness or fatigue. Any potential side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 10 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days).
This trial's timeline: 3 weeks for screening, Varies for treatment, and psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).

Side effects data

From 2020 Phase 3 trial • 930 Patients • NCT03545191
9%
Nasopharyngitis
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daridorexant 25 mg
Daridorexant 50 mg
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Daridorexant 50 mgExperimental Treatment1 Intervention
Group II: Daridorexant 25 mgExperimental Treatment1 Intervention
Group III: Daridorexant 10 mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daridorexant 10 mg
2023
Completed Phase 3
~850
Daridorexant 25 mg
2023
Completed Phase 3
~1810
Daridorexant 50 mg
2018
Completed Phase 3
~1770

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
118 Previous Clinical Trials
32,307 Total Patients Enrolled
1 Trials studying Insomnia
100 Patients Enrolled for Insomnia
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,198 Previous Clinical Trials
888,298 Total Patients Enrolled

Media Library

Daridorexant (Orexin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05423717 — Phase 2
Insomnia Research Study Groups: Placebo, Daridorexant 25 mg, Daridorexant 50 mg, Daridorexant 10 mg
Insomnia Clinical Trial 2023: Daridorexant Highlights & Side Effects. Trial Name: NCT05423717 — Phase 2
Daridorexant (Orexin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423717 — Phase 2
Insomnia Patient Testimony for trial: Trial Name: NCT05423717 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Florida
How old are they?
18 - 65
What site did they apply to?
Florida Pediatric Research Institute
NeuroTrials Research, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need sleep.
PatientReceived 2+ prior treatments
~53 spots leftby Mar 2025