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A study to find out if daridorexant is safe and efficacious to treat insomnia in patients with insomnia and comorbid nocturia
EU CTIS ID: 2022-501246-30-00
What this study is testing
To assess whether daridorexant improves insomnia in subjects with insomnia and comorbid nocturia.
- Therapeutic use (Phase IV)
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
- Signed and dated ICF prior to any study-mandated procedure.
- Male or female subjects ≥ 55 years old at the time of signing the ICF.
- Insomnia complaints for at least 3 months prior to Visit 1.
- ISI© score ≥ 13 at Visit 1.
- Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.
- Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.
You likely can't join if
- Woman of childbearing potential, pregnant or plans to become pregnant.
- Planned travel across ≥ 3 time zones during study.
- Life time history of suicidality assessed via C-SSRS©.
- Regular caffeine consumption after 4 pm.
- Unable to refrain from smoking during the night.
- Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or REM sleep behavior disorder.
See the full eligibility criteria
- Signed and dated ICF prior to any study-mandated procedure.
- Male or female subjects ≥ 55 years old at the time of signing the ICF.
- Insomnia complaints for at least 3 months prior to Visit 1.
- ISI© score ≥ 13 at Visit 1.
- Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.
- Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.
- Woman of childbearing potential, pregnant or plans to become pregnant.
- Planned travel across ≥ 3 time zones during study.
- Life time history of suicidality assessed via C-SSRS©.
- Regular caffeine consumption after 4 pm.
- Unable to refrain from smoking during the night.
- Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or REM sleep behavior disorder.
- Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, and central or nephrogenic diabetes insipidus, and primary/secondary polydipsia within the last 6 months prior to Visit 1.
- Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1.
- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.