Daridorexant treatment in adolescents with enuresis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

11 Mar 2026 → ongoing

Decision date (initial)

2025-07-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To examine the efficacy of daridorexant treatment in adolescents.

Secondary objectives 2

1. To evaluate if daridorexant treatment affects the nocturnal urine output or estimated nocturnal bladder capacity following four weeks of treatment.
2. To examine the safety of daridorexant treatment in adolescents.

Conditions and MedDRA coding

Nocturnal enuresis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age 15-17 years.
2. Primary nocturnal enuresis (at least 3 wet nights/week).
3. No response to eight weeks of alarm treatment or two weeks of desmopressin treatment or contraindications against one of the two treatments.

Exclusion criteria 14

1. 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.
2. 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.
3. Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
4. Former operations in the urinary tract.
5. Body weight < 25 kg.
6. 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.
7. 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).
8. 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©).
9. 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).
10. Breathing difficulties such as severe asthma or severe chronic obstructive pulmonary disease.
11. No history or actual abuse or addiction to alcohol or other substances.
12. Known hypersensitivity / allergy to substances in the tablets.
13. Female subjects of childbearing potential who are not using adequate contraceptives.
14. Pregnant or lactating female subjects.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in wet nights/week.

Secondary endpoints 6

1. Nocturnal urine production.
2. Bladder capacity (maximum voided volume).
3. Nocturnal bladder capacity.
4. Adverse events.
5. Termination of the treatment.
6. Number of participants with full- and partial response

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Palle Juul-Jensens Boulevard 99

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Region Midtjylland

Contact name

Søren Rittig

Public contact point

Organisation

Region Midtjylland

Contact name

Cecilie Siggaard Jørgensen

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications