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Orexin Antagonist
Daridorexant for Insomnia
Verified Trial
Phase 4
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
Be older than 18 years old
Timeline
Screening 21 days
Treatment 3 months
Follow Up 10 days
Awards & highlights
Summary
This trial tests daridorexant, a medication that helps people sleep better, on those who have trouble sleeping and frequently wake up at night to urinate. It works by calming brain activity to improve sleep. Daridorexant is a newly approved treatment for insomnia.
Who is the study for?
This trial is for men and women over 55 who have trouble sleeping (insomnia) and need to urinate at least three times a night (nocturia). They should be able to communicate clearly, understand the study's requirements, have an ISI© score ≥ 13, own a smartphone, and have had these sleep issues for at least three months.
What is being tested?
The study is testing Daridorexant's effectiveness in improving sleep among those with insomnia and frequent nighttime urination. Participants will either receive Daridorexant or a placebo (a pill without active medication), to compare outcomes between the two groups.
What are the potential side effects?
While specific side effects of Daridorexant are not listed here, common ones may include drowsiness during the day, headache, dizziness or lightheadedness. Side effects can vary from person to person.
Timeline
Screening ~ 21 days1 visit
Treatment ~ 3 months5 visits
Follow Up ~ 10 days2 visits
Screening ~ 21 days
Treatment ~ 3 months
Follow Up ~10 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to Week 4 in subjective total sleep time (sTST)
Side effects data
From 2020 Phase 3 trial • 924 Patients • NCT0357510412%
Nasopharyngitis
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daridorexant 10 mg
Daridorexant 25 mg
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg daridorexantExperimental Treatment1 Intervention
Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daridorexant
2020
Completed Phase 3
~1090
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for insomnia include benzodiazepines, non-benzodiazepine hypnotics (e.g., zolpidem), melatonin receptor agonists (e.g., ramelteon), and Dual Orexin Receptor Antagonists (DORAs) like daridorexant. Benzodiazepines and non-benzodiazepine hypnotics enhance the effect of the neurotransmitter GABA, promoting sedation.
Melatonin receptor agonists mimic the sleep-regulating hormone melatonin, aiding in sleep onset. DORAs, such as daridorexant, work by blocking orexin receptors, which play a role in wakefulness, thereby promoting sleep.
Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the specific sleep issues and potential side effects, leading to better management of insomnia.
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,903 Total Patients Enrolled
3 Trials studying Insomnia
1,035 Patients Enrolled for Insomnia
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,212 Previous Clinical Trials
892,366 Total Patients Enrolled
1 Trials studying Insomnia
150 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score of 13 or higher on the ISI© at Visit 1.You have signed and dated the ICF prior to any study-mandated procedure.I can communicate clearly and understand the study's needs.I am 55 years old or older.I own a smartphone.I have trouble sleeping and have complained about it.I have been getting up to urinate at least 3 times every night for the past month.I am 54 years old or older.You drink caffeinated beverages regularly after 4 pm.I have had trouble sleeping for at least 3 months.I go to the bathroom to urinate 3 or more times a night for at least a month.
Research Study Groups:
This trial has the following groups:- Group 1: 50 mg daridorexant
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 21 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 10 Months after you stop receiving the treatment.
Insomnia Patient Testimony for trial: Trial Name: NCT05597020 — Phase 4
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