Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Daridorexant: Daridorexant tablets administered orally once nightly for 30 days at a dose of 25 mg or 50 mg according to liver function and the study protocol. The maximum dose for participants with Child-Pugh class B liver function is 25 mg per night.

Placebo: Matching placebo administered orally once daily for 30 days.

Study summary

This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.

Eligibility

Primary outcome measure(s)

• Percent Improvement From Baseline in Sleep Efficiency at Day 30 — Baseline and Day 30
  Sleep efficiency (SE) is measured by overnight polysomnography (PSG) and expressed as the percentage of time in bed spent asleep. PSG is performed at baseline and on Days 7, 14, and 30. The primary outcome is the relative percent change in SE from baseline to Day 30.

Trial sites (3)

Other trials for the same condition