Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07830303

Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Liver Cirrhosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tianjin First Central Hospital, Tianjin, Tianjin Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-60 years.
  • Confirmed liver cirrhosis based on imaging, pathology, or clinical diagnosis.
  • Child-Pugh class A or B liver function; participants with hepatic encephalopathy must have covert hepatic encephalopathy (minimal hepatic encephalopathy [MHE]) or West-Haven grade I hepatic encephalopathy.
  • Insomnia supported by both subjective and objective evidence, including a Pittsburgh Sleep Quality Index (PSQI) total score >5 and objective polysomnography (PSG) or actigraphy findings.
  • Provision of written informed consent.

Exclusion criteria

  • Age <18 years or >60 years.
  • Child-Pugh class C liver function.
  • Overt hepatic encephalopathy of West-Haven grade II or higher.
  • Concomitant use of strong CYP3A4 inhibitors, such as itraconazole or ketoconazole, or strong CYP3A4 inducers, such as carbamazepine or rifampin.
  • Severe respiratory insufficiency or uncontrolled severe obstructive sleep apnea.
  • Pregnancy or breastfeeding.
  • Narcolepsy.
  • Known hypersensitivity to daridorexant or any of its excipients.
  • Concomitant use of central nervous system depressants, including alcohol, benzodiazepines, or opioids, that may increase sedation or somnolence.
  • Active severe psychiatric disorders, such as depression with suicidal ideation or a history of suicidal ideation, or a history of substance abuse.
  • Any contraindication to daridorexant.

Treatment and study plan

Daridorexant

Drug

Daridorexant tablets administered orally once daily for 30 days. The dose is 25 mg or 50 mg according to liver function.

Placebo

Drug

Matching placebo administered orally once daily for 30 days.

Primary outcomes

  1. Percent Improvement From Baseline in Sleep Efficiency at Day 30

    Time frame: Baseline and Day 30

    Sleep efficiency (SE) measured by overnight polysomnography (PSG). The primary endpoint is the percent improvement in sleep efficiency from baseline to Day 30.

Secondary outcomes

  1. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at Day 30

    Time frame: Baseline and Day 30

    The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in the PSQI total score from baseline to Day 30.

  2. Change From Baseline in Sleep Latency at Day 30

    Time frame: Baseline and Day 30

  3. Change From Baseline in Total Sleep Time at Day 30

    Time frame: Baseline and Day 30

  4. Change From Baseline in SWS/REM Sleep Ratio at Day 30

    Time frame: Baseline and Day 30

  5. Change From Baseline in Microarousal Frequency at Day 30

    Time frame: Baseline and Day 30

  6. Change in Psychometric Hepatic Encephalopathy Score (PHES)

    Time frame: Baseline, Day 7, Day 14, and Day 30

    The Psychometric Hepatic Encephalopathy Score (PHES) ranges from -15 to +5, with higher scores indicating better cognitive performance. The outcome is the change in PHES during the study.

  7. Change From Baseline in Stroop EncephalApp Performance at Day 30

    Time frame: Baseline and Day 30

  8. Proportion of Participants With Reversal of Minimal Hepatic Encephalopathy by Day 30

    Time frame: Baseline through Day 30

  9. Incidence of Overt Hepatic Encephalopathy by Day 30

    Time frame: From baseline through Day 30

Study contacts

Contact information is provided by the study sponsor or research team.

Fengmei Wang

CONTACT

[email protected]

15522242696

Sponsors and collaborators

Lead sponsor

Wang Fengmei

Other

Registry information

Official study title

Efficacy and Safety of a Novel Dual Orexin Receptor Antagonist in Patients With Sleep Disturbance and Hepatic Encephalopathy

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.