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A Study of E2086 for Adults with Narcolepsy

This study is looking into a new oral tablet called E2086 for adults who have narcolepsy. Researchers want to see if E2086 can help reduce excessive daytime sleepiness (EDS) compared to a placebo (an inactive tablet that looks like the study drug). The main goal is to find the best dose of E2086 by measuring how long people can stay awake during a special test called the Maintenance of Wakefulness Test (MWT). You may be able to join if you are 18 years or older and have narcolepsy. The study plans to enroll 64 participants, but its current status is unclear.

Study design
This is an interventional study comparing E2086 to a placebo in about 64 participants with narcolepsy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Baseline and Week 4, suggesting a follow-up period of at least 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07493265

A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Eisai Inc.
~64 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:E2086Placebo

At a glance

Recruiting sites
2 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2
Measured over Baseline and Week 4

Conditions

Narcolepsy

Explore related trials

NarcolepsyNarcolepsy type 1Narcolepsy without CataplexyOrexin A

Where it's being run

57 sites across 30 states
Spain8
Florida5
Ontario4
Germany4
Georgia3
Michigan3
Italy3
South Korea3

Who to contact

Eisai Medical Information
[email protected]
+1-888-274-2378
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, and clinical history, consistent with the 2023 International Classification of Sleep Disorders, 3rd edition, text revision (ICSD-3-TR) criteria for NT1
Cerebrospinal fluid orexin-A/hypocretin-1 concentration less than or equal to (\<=) 110 picograms per milliliter (pg/mL) 2. At least 4 or more episodes of cataplexy/week as averaged over 2 weeks minimum and confirmed by the cataplexy portion of the Diary If PSG or MSLT results are not available within the last 10 years of screening to fulfill Criterion 2a then screening assessment results for PSG or MSLT can be used instead 3. NT2 Cohort: Diagnosis of NT2 within the last 10 years of screening, as confirmed by PSG and MSLT results, and clinical history, consistent with the 2023 ICSD-3-TR criteria for NT2 If PSG or MSLT results are not available within the last 10 years of screening to fulfill Criterion 3 then screening assessment results for PSG or MSLT can be used instead 4. ESS score \>=10 5. Reports regular bedtime, defined as the time that the participant attempts to sleep, between 22:00 and 01:00 (based on data from the screening Diary) 6. Reports regular waketime, defined at the time the participant gets out of bed for the day, between 05:00 and 10:00 (based on data from the screening Diary) 7. Reports being in bed between 7 and 9 hours per night (based on data from the sleep portion of the Diary) 8. Compliance rate \>=80 percentage (%) for completion of the Diary during screening 9. Body mass index (BMI) \>=18 to less than (\<) 35 kilograms per square meter (kg/m\^2) at Screening

Exclusion

Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.

What this trial measures

  • Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2Baseline and Week 4

    Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective measure of the ability to stay awake. An increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. The first 4 measurements of sleep latency at regular intervals across the day are averaged to calculate the MSL. The MWT is used to evaluate response to treatment for conditions associated with EDS and to assess alertness in individuals who must remain awake for safety reasons. The 40-minute MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine (AASM).