Ramelteon for Treatment of Insomnia in Cirrhosis

NCT03091738 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: HM139685R01DK087913
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of ramelteon, a melatonin receptor agonist, on sleep quality, duration and cognitive function in cirrhotics with insomnia. Patients with cirrhosis have difficulties with their sleep quality, which adversely affects their health-related quality of life. It is assumed the sleep disturbances are related to hepatic encephalopathy (HE) in these patients. However, several recent reports have indicated that this is not a perfect concordance and that cognition is not related to sleep disturbance. The mechanism for this change is not clear, although there is evidence of melatonin-delayed phase in these patients as well as difficulties with the excretion pattern of cortisol. Ghrelin is an orexigenic hormone produced by the stomach which stimulates the appetite and also has a profound effect on sleep. Our group has demonstrated a substantial alteration in ghrelin secretion in cirrhosis that correlates with poor slow-wave sleep. In healthy individuals, ghrelin injection encourages slow-wave sleep while sleep deprivation increases ghrelin levels. The role of ghrelin in the sleep disturbances of cirrhosis has not been determined. Prior studies have also lacked the use of overnight polysomnography as a tool and have relied on either actigraphy or questionnaires. There is a need for detailed mechanistic and therapeutic approaches to analyzing sleep disturbances in cirrhosis. Also the therapy of sleep disturbance in cirrhosis is largely empirical. Prior studies have evaluated hydroxyzine which runs the risk of precipitating HE. Ramelteon is a melatonin analog that is FDA-approved for use in insomnia and will potentially be useful to restore the sleep-wake cycle in cirrhosis-associated sleep disturbance. The investigators aim to study the impact of the FDA-approved ramelteon on the sleep quality (using questionnaires and sleep diaries) on these patients with cirrhosis.

Conditions

Cirrhosis

Keywords

sleep

Outcome Measures

Primary Outcomes (1)

• Sleep Quality Evaluation

  Pittsburgh Sleep Quality Index (PSQI) is a 19 item survey measuring 7 components of sleep. Component scores are summed to yield a global PSQI score. Scores range from 0 to 21 with higher scores indicate worse sleep quality.

  14 days

Secondary Outcomes (2)

• Daytime Sleepiness Evaluation

  14 days

• Sickness Impact Profile

  14 days

Study Arms (1)

Ramelteon Pill

EXPERIMENTAL

Patients given ramelteon and re-evaluated after 15 days of therapy

Drug: Ramelteon Pill

Interventions

Ramelteon Pill DRUG

Patients with compensated cirrhosis and insomnia will be provided ramelteon

Also known as: Ramelteon

Ramelteon Pill

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Child class A cirrhosis proven by biopsy, radiology or endoscopic evidence of varices - Able to give informed consent

You may not qualify if:

• Patient unwilling to start therapy
• Allergic reactions to ramelteon in the past
• Obstructive sleep apnea
• Periodic limb movement disorder
• Moderate to severe depression
• Unable to give informed consent
• Night shift workers
• Inter-continental travel within the last 4 weeks
• Renal insufficiency on dialysis
• Current alcohol or illicit drug use
• Diabetes Mellitus using insulin therapy
• Use of chronic hypnotic medications more than once per week or more than 5-6 times per month

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Fibrosis

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jasmohan Bajaj, MD
• Organization: Virginia Commonwealth University

jasmohan.bajaj@vcuhealth.org

804-828-4060

Study Officials

• Jasmohan S Bajaj, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: February 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 29, 2021
• Results First Posted: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)