BridgeMD
Daridorexant treatment in adolescents with enuresis.
EU CTIS ID: 2025-521443-20-00
What this study is testing
To examine the efficacy of daridorexant treatment in adolescents.
- Therapeutic confirmatory (Phase III)
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
- Age 15-17 years.
- Primary nocturnal enuresis (at least 3 wet nights/week).
- No response to eight weeks of alarm treatment or two weeks of desmopressin treatment or contraindications against one of the two treatments.
You likely can't join if
- The need for any medication during the study period, which cannot be pause two weeks before the first treatment dose, except for paracetamol and laxatives at any kind.
- Breathing difficulties such as severe asthma or severe chronic obstructive pulmonary disease.
- No history or actual abuse or addiction to alcohol or other substances.
- Known hypersensitivity / allergy to substances in the tablets.
- Female subjects of childbearing potential who are not using adequate contraceptives.
- Pregnant or lactating female subjects.
See the full eligibility criteria
- Age 15-17 years.
- Primary nocturnal enuresis (at least 3 wet nights/week).
- No response to eight weeks of alarm treatment or two weeks of desmopressin treatment or contraindications against one of the two treatments.
- The need for any medication during the study period, which cannot be pause two weeks before the first treatment dose, except for paracetamol and laxatives at any kind.
- Breathing difficulties such as severe asthma or severe chronic obstructive pulmonary disease.
- No history or actual abuse or addiction to alcohol or other substances.
- Known hypersensitivity / allergy to substances in the tablets.
- Female subjects of childbearing potential who are not using adequate contraceptives.
- Pregnant or lactating female subjects.
- Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated or prevent the participant in complying with the study requirements.
- Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
- Former operations in the urinary tract.
- Body weight < 25 kg.
- Any lifetime history of sleep-related breathing disorders, such as obstructive sleep apnea, based on the subject’s medical record. If the breathing disorder has been treated by tonsillectomy/adenoidectomy, the participant remains eligible.
- Any other diagnosed sleep-wake disorder as defined in DSM-5 or ICSD-3 (e.g. restless legs syndrome, circadian rhythm sleep-wake disorder, parasomnias, or narcolepsy).
- Any suicidal ideation with or without a plan (“yes” to question 1 or 2 on the C- SSRS©) or a history of suicide attempt (“yes” to question 6 on the C-SSRS©).
- ASAT or ALAT and direct bilirubin in the normale range (standard reference values from AUH) or a history of severe lever impairment. (The test must be maximum 6 months old).
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
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.