DARIDOREXANT for Nocturnal enuresis

Inclusion criteria

• {"criterion_text":"- Age 15-17 years.\n- Primary nocturnal enuresis (at least 3 wet nights/week).\n- No response to eight weeks of alarm treatment or two weeks of desmopressin treatment or contraindications against one of the two treatments."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Breathing difficulties such as severe asthma or severe chronic obstructive pulmonary disease.\n- No history or actual abuse or addiction to alcohol or other substances.\n- Known hypersensitivity / allergy to substances in the tablets.\n- Female subjects of childbearing potential who are not using adequate contraceptives.\n- Pregnant or lactating female subjects.\n- 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.\n- Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.\n- Former operations in the urinary tract.\n- Body weight < 25 kg.\n- 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.\n- 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).\n- 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©).\n- 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)."}

Primary endpoints

• {"endpoint_text":"- Change in wet nights/week.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Nocturnal urine production.\n- Bladder capacity (maximum voided volume).\n- Nocturnal bladder capacity.\n- Adverse events.\n- Termination of the treatment.\n- Number of participants with full- and partial response","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

08-07-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

10

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP enhederne","duties_or_roles":"1","organisation_type":"Regulatory Authority"}