Lemborexant for Post-operative Delirium
(PROTEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Lemborexant, a drug originally used for sleep issues, can reduce delirium (a sudden change in mental state) after heart surgery. Delirium commonly affects those recovering from heart surgeries, impacting recovery and overall health. Participants will receive either Lemborexant or a placebo (a pill resembling the drug but without active ingredients) for seven days post-surgery. The trial seeks individuals who have undergone open-heart surgery but do not have severe sleep apnea, restless legs, or certain other medical conditions. As a Phase 2 trial, this research measures Lemborexant's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking moderate or strong CYP3A inhibitors or frequently use medications for insomnia more than 4 days a week.
Is there any evidence suggesting that Lemborexant is likely to be safe for humans?
A previous study found lemborexant safe for patients with pancreato-biliary disease. Importantly, it did not increase the risk of confusion or disorientation (delirium) in those patients, although some mild side effects were reported. The FDA has already approved lemborexant for treating insomnia, which further supports its safety. This approval indicates it is safe for treating sleep problems. However, its use in preventing confusion after surgery remains under study. The current trial phase focuses on assessing its safety and effectiveness for this new purpose, and more data will help confirm its safety for this specific use.12345
Why do researchers think this study treatment might be promising for delirium?
Lemborexant is unique because it targets the orexin system to manage post-operative delirium, unlike most standard treatments that often focus on managing symptoms with antipsychotics or sedatives. This novel mechanism may help regulate sleep-wake cycles more effectively and with fewer side effects. Researchers are excited about Lemborexant because it has the potential to reduce delirium episodes quickly and improve recovery times, offering a promising alternative to traditional approaches.
What evidence suggests that Lemborexant might be an effective treatment for post-operative delirium?
Research has shown that lemborexant, a medication originally approved for sleep problems, might help reduce the risk of confusion after surgery, known as post-operative delirium. One study found that patients who took lemborexant had a 75% lower risk of developing delirium compared to those who did not take it. Another study showed that lemborexant did not worsen delirium in patients with sleep issues. These findings suggest that lemborexant could help manage delirium by improving sleep, which often gets disrupted after surgery. In this trial, participants in the intervention arm will receive lemborexant to evaluate its effectiveness in preventing delirium after surgery. While more research is needed, these early results are promising for its use in preventing delirium after heart surgery.12467
Are You a Good Fit for This Trial?
This trial is for cardiac surgery patients who may be at risk of post-operative delirium, a condition that can lead to increased mortality. The study aims to include those who could benefit from a drug therapy designed to prevent this complication.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lemborexant or placebo daily for 7 days post-operatively while in hospital
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of delirium and sleep quality
Post-discharge Follow-up
Participants are monitored for any adverse effects and overall recovery post-hospital discharge
What Are the Treatments Tested in This Trial?
Interventions
- Lemborexant
Lemborexant is already approved in United States, Canada, Japan for the following indications:
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance, with or without associated impairment in daily functioning
- Treatment of insomnia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
St. Paul's Hospital, Vancouver (Providence Health Care)
Collaborator
Providence Health Care, British Columbia
Collaborator
Eisai Inc.
Industry Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University