A multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post approval study to investigate the efficacy of daridorexant in subjects with insomnia and comorbid nocturia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501246-30-00

Acronym

ID-078A401

Enrollment

Registered

2023-03-02

Start date

2023-03-08

Completion date

2024-04-17

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Disorder, Nocturia

Brief summary

Change from baseline to Week 4 in subjective total sleep time (sTST).

Interventions

DRUGdaridorexant placebo matching film-coated tablets

DRUGQUVIVIQ 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 4 in subjective total sleep time (sTST).	—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026