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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

Study Summary

This trial will study the effects of a new drug on insomnia and nighttime urination in people with both conditions.

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.Check my eligibility
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.See study design
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 days
Treatment ~ 3 months
Follow Up ~10 days
This trial's timeline: 21 days for screening, 3 months for treatment, and 10 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 Week 4 in subjective total sleep time (sTST)

Side effects data

From 2020 Phase 3 trial • 924 Patients • NCT03575104
12%
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

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
118 Previous Clinical Trials
32,407 Total Patients Enrolled
2 Trials studying Insomnia
250 Patients Enrolled for Insomnia
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,198 Previous Clinical Trials
888,541 Total Patients Enrolled
1 Trials studying Insomnia
150 Patients Enrolled for Insomnia

Media Library

Daridorexant (Orexin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05597020 — Phase 4
Insomnia Research Study Groups: 50 mg daridorexant, Placebo
Insomnia Clinical Trial 2023: Daridorexant Highlights & Side Effects. Trial Name: NCT05597020 — Phase 4
Daridorexant (Orexin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597020 — Phase 4
Insomnia Patient Testimony for trial: Trial Name: NCT05597020 — Phase 4

Frequently Asked Questions

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

How many healthcare facilities are actively involved in this research?

"Currently, the study is running at 5 sites across multiple cities: Hialeah, San Bernardino and New york among others. For those interested in participating, it's beneficial to select a location that requires minimal travel."

Answered by AI

Has the FDA sanctioned a dosage of 50mg for daridorexant?

"The safety of 50 mg daridorexant was determined to be a 3, as this is an approved Phase 4 trial."

Answered by AI

Are there any opportunities for prospective participants to partake in this clinical trial?

"Contrary to current expectations, clinicaltrials.gov indicates that this medical trial is no longer signing up patients; the original posting date was December 15th 2022 and it has since been edited on November 15th 2022. Despite this fact, 220 other trials are still accepting participants at present."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
Florida
How old are they?
18 - 65
What site did they apply to?
Baylor College of Medicine
Other
Urology Research Network
Clinical Research Center of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

How long does the visit take? Do you supply transportation? Is this trial for a sleeping pill?
PatientReceived 2+ prior treatments
Is there also compensation, if so how much? What's the drug? If not a drug, what's the basic therapy? Includes a placebo?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Insomnia really bad. To improve my sleep. I hate that I can't sleep. I have nocturia and insomnia.
PatientReceived no prior treatments
Sleeping problems with anxiety.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Urology Research Network: < 24 hours
  2. Clinical Research Center of Florida: < 24 hours
Average response time
  • < 2 Days
~0 spots leftby Apr 2024