E2086 for Narcolepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, E2086, to evaluate its effectiveness for people with narcolepsy, a condition that causes excessive daytime sleepiness. The goal is to determine the optimal dose that reduces daytime sleepiness compared to a placebo (a pill without active medication). Participants will receive either the actual treatment or a placebo over several weeks. This trial may suit those diagnosed with narcolepsy within the past 10 years who experience regular episodes of cataplexy (sudden muscle weakness) or excessive daytime sleepiness. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that E2086 is likely to be safe for humans?
Research has shown that E2086 is generally safe for people with narcolepsy. Previous studies found that most side effects were mild or moderate, causing slight discomfort for some, while serious side effects remain rare.
E2086 helps people stay awake by targeting specific parts of the brain. Earlier research suggests it can improve daytime alertness for those with narcolepsy.
Although more studies are needed to confirm these results, the current phase of research appears promising for safety.12345Why do researchers think this study treatment might be promising for narcolepsy?
Researchers are excited about E2086 for narcolepsy because it introduces a novel approach to tackling this sleep disorder. Unlike traditional treatments like modafinil or sodium oxybate, which generally aim to promote wakefulness or manage symptoms, E2086 potentially works through a different mechanism. Although specific details about this mechanism aren't widely publicized, the prospect of a new active ingredient offers hope for those who may not respond well to existing options. Additionally, E2086's structured dosing across low, middle, and high levels could provide more individualized treatment outcomes, potentially leading to better management of narcolepsy symptoms.
What evidence suggests that E2086 might be an effective treatment for narcolepsy?
Research has shown that E2086 may help treat excessive daytime sleepiness in people with narcolepsy type 1. In this trial, participants with narcolepsy type 1 will receive E2086, which studies have found can help people stay awake during the day by targeting a part of the brain that controls wakefulness. For narcolepsy type 2, early research suggests that E2086 can increase the time people stay awake and reduce episodes similar to sudden muscle weakness. Participants with narcolepsy type 2 in this trial will also receive E2086. These findings suggest that E2086 might effectively manage symptoms of narcolepsy.12467
Are You a Good Fit for This Trial?
This trial is for adults (18+) diagnosed with narcolepsy type 1 or type 2, who have regular sleep schedules and significant daytime sleepiness. Participants must meet specific diagnostic criteria and keep a consistent bedtime and wake time.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive E2086 or placebo once daily for 4 weeks during each of the low-, middle-, and high-dose-matched treatment periods, with a washout period of at least 7 days between dose levels
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of ECG, laboratory values, vital signs, and suicidality
What Are the Treatments Tested in This Trial?
Interventions
- E2086
Trial Overview
The study compares different doses of a new drug called E2086 to a placebo in adults with narcolepsy, aiming to see if E2086 can reduce excessive daytime sleepiness. The design randomly assigns participants to receive either the drug or placebo.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants with NT2 will be randomly assigned to receive one E2086 tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
Participants with NT1 will be randomly assigned to receive one E2086 tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
Participants with NT1 will be randomly assigned to receive one E2086 matched placebo tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
Participants with NT2 will be randomly assigned to receive one E2086 matched placebo tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eisai Inc.
Lead 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
Citations
Eisai Presents Clinical Study Results of Novel Orexin ...
These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 ( ...
A Study to Evaluate the Efficacy and Safety of E2086 ...
The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for ...
A Comprehensive Review of Current and Emerging ... - PMC
In narcolepsy type 1, loss of orexin signaling leads to two core symptoms: excessive daytime sleepiness due to inadequate arousal drive and REM ...
4.
clinicaltrial.be
clinicaltrial.be/en/details/447264?per_page=20&only_recruiting=0&only_eligible=0&only_active=0A Study to Evaluate the Efficacy, Safety, and Tolerabilit...
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of ...
Eisai Presents Clinical Study Results of Novel Orexin ...
These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 ( ...
NCT06462404 | A Study to Evaluate the Efficacy, Safety ...
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1.
7.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-e2086-compared-to-placebo-and-active-cA Study to Evaluate the Efficacy, Safety, and Tolerability of ...
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of ...
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