New pill aims to keep narcolepsy patients awake and safe

NCT ID NCT07493265

Symptom relief Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether E2086, an oral tablet, can reduce excessive daytime sleepiness in adults with narcolepsy. About 64 participants will receive either the drug or a placebo for 4 weeks. Researchers will measure how long people can stay awake using a standard test, and also track any sudden muscle weakness episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: E2086 oral tablets
What this could lead to: If successful, this could point toward a new treatment option to help people with narcolepsy stay awake during the day and reduce sudden muscle weakness episodes.
What could go wrong: This is an early Phase 2 trial with only 64 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age greater than or equal to (\>=) 18 years (or as regionally appropriate) at the time of informed consent 2. NT1 Cohort: Must fulfill Inclusion Criteria 2a and 2b 1. Diagnosis of NT1 within the last 10 years of screening, as confirmed by at least one of the following: * 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 Criteria: 1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[ß-hCG\] (or human chorionic gonadotropin \[hCG\]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of ß-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug 2. Females of childbearing potential who: * Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following: 1. total abstinence (if it is their preferred and usual lifestyle) 2. an intrauterine device or intrauterine hormone-releasing system (IUS) 3. a contraceptive implant 4. Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study and for at least 28 days following study drug discontinuation 5. have a vasectomized partner with confirmed azoospermia * 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. Participants on an oral contraceptive must use an additional study method throughout the study and for 28 days after study drug discontinuation. For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). 3. Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing 4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (for example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system) 5. Any history of surgery that may affect PK profiles of E2086 (for example, hepatectomy, nephrectomy, digestive organ resection) or who have a congenital abnormality in metabolism at Screening 6. Any clinically abnormal symptom or organ impairment found by medical history at Screening, including severe renal impairment (estimated glomerular filtration rate \[eGFR\] \<30 milliliters per minute (mL/min), and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment at Screening or Baseline 7. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 milliseconds (ms) according to central reading at Screening or Baseline. If the QTcF machine read is greater than 450 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be calculated 8. Persistent systolic BP greater than (\>) 130 or \<100 millimeters of mercury (mmHg) or diastolic BP \>85 or \<50 mmHg at Screening (based on BP measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, BP should be repeated twice with at least 5 minutes between measurements 9. Persistent HR less than 50 beats/min or more than 100 beats/min at Screening (based on HR measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, HR should be repeated twice with at least 5 minutes between measurements 10. Any lifetime history of suicidal behavior as indicated by the C-SSRS 11. Current unstable psychiatric disorder, current active major depressive episode or an active major depressive episode in the past 6 months 12. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) 13. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening 14. Hypersensitivity to the study drug or any of the excipients 15. Intake of herbal preparations containing St. John's Wort within 5x the half-life before dosing 16. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study 17. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety 18. Known to be human immunodeficiency virus (HIV) positive 19. Acute Epstein Barr virus (EBV) infection with a positive EBV Viral Capsid Antigen Antibody (VCA) IgM at Baseline 20. Known to be hepatitis B virus (HBV)-positive with a detectable HBV (for example, hepatitis B surface antigen \[HBsAg\] reactive) within 6 months before the 1st dose of study drug, or hepatitis C virus (HCV) positive with a detectable (for example, HCV ribonucleic acid (RNA) \[qualitative\]) viral load. Note: Participants who are HCV positive due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained and the participant has completed active treatment 21. Initiation of statin therapy, or a change to a different statin, or an increase in the dose of a statin within the 6 months before the planned start of study drug 22. History of formally diagnosed moderate to severe obstructive sleep apnea (OSA) 23. Current use of continuous positive airway pressure (CPAP), hypoglossal nerve stimulator, oral device, or other therapy for the treatment of OSA 24. Symptomatic restless legs syndrome 25. Apnea-hypopnea index \>=15 on Screening PSG 26. Use of anticataplectic medications (including but not limited to antidepressants) within 5× the half-life before Screening 27. Use of psychostimulant medications, prescription and over-the-counter (OTC), within 5× the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medications include OTC stimulants (for example, pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pitolisant, solriamfetol, and pemoline 28. Use of sleep promoting or sedating medications, prescription and OTC, within 5x the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medication include OTC sleep aids, trazodone, hypnotics, benzodiazepines, barbiturates,cannabinoids, melatonin, melatonin receptor agonists, dual orexin receptor antagonists, and opioids 29. Inability to discontinue use of strong (such as antifungal itraconazole and antibiotic clarithromycin) and moderate (such as antifungal fluconazole) Cytochrome P450 3A (CYP) 3A inhibitors within 5x the half-life before dosing until after the Follow-Up Visit 30. Inability to discontinue use of CYP3A inducers (such as antibiotic rifampicin and anti-convulsant phenytoin) within 5x the half-life before dosing until after the Follow-Up Visit 31. History of drug or alcohol dependency or abuse within 2 years before Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline 32. Does not agree to abstain from use of recreational drugs during the study 33. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5x the half-life, whichever is longer, preceding informed consent 34. Receipt of blood products within 4 weeks of dosing, donation of blood within 8 weeks of dosing, or donation of plasma within 1 week of dosing 35. Past participation in a study of an orexin agonist if discontinuation of orexin agonist use was related to an adverse drug reaction or inefficacy

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Conditions

The condition(s) this trial relates to.

narcolepsy narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Narcolepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

57 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AMNDX, Inc
NOT_YET_RECRUITING

Markham, Ontario, L3R1A3, Canada
ANIMA Research Center
NOT_YET_RECRUITING

Alken, 3570, Belgium
Advanced Sleep Research GmbH
NOT_YET_RECRUITING

Berlin, 10117, Germany
Alexianer St. Hedwig Kliniken Berlin GmbH
NOT_YET_RECRUITING

Berlin, 10115, Germany
Anchor Medical Research LLC
NOT_YET_RECRUITING

Miami, Florida, 33176, United States
Bogan Sleep Consultants, LLC
RECRUITING

Columbia, South Carolina, 29201, United States
CaRe Clinic - Calgary - HyperCore - PPDS
NOT_YET_RECRUITING

Calgary, Alberta, T2N 4L7, Canada
Centricity Research - CPU - Bayview
NOT_YET_RECRUITING

Toronto, Ontario, M4P 1P2, Canada
Centro Ricerche Cliniche Di Verona
NOT_YET_RECRUITING

Verona, 37134, Italy
Clinical Research Institute Stockbridge
NOT_YET_RECRUITING

Stockbridge, Georgia, 30291, United States
Corporacio Sanitaria Parc Tauli
NOT_YET_RECRUITING

Barcelona, 08208, Spain
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
NOT_YET_RECRUITING

Pavia, 27100, Italy
Future Search Trials of Neurology
NOT_YET_RECRUITING

Austin, Texas, 78731, United States
Gokeikai Osaka Kaisei Hospital
NOT_YET_RECRUITING

Oskaka, Osaka, 532-0003, Japan
Henan Provincial People's Hospital
NOT_YET_RECRUITING

Zhengzhou, Zhengzhou, 450003, China
Henry Ford Medical Center - Columbus
NOT_YET_RECRUITING

Novi, Michigan, 48377, United States
Hope Research Network Trials -6500 NW 77th CT
NOT_YET_RECRUITING

Medley, Florida, 33166, United States
Hospital Blua Sanitas Valdebebas
NOT_YET_RECRUITING

Madrid, 28055, Spain
Hospital HM Puerta del Sur
NOT_YET_RECRUITING

Móstoles, 28936, Spain
Hospital Ruber Internacional
NOT_YET_RECRUITING

Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
NOT_YET_RECRUITING

Madrid, 28040, Spain
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING

Seville, 41009, Spain
Hospital Universitario de Donostia
NOT_YET_RECRUITING

Donostia / San Sebastian, 20014, Spain
Hospital Universitario de La Ribera
NOT_YET_RECRUITING

Alzira, 46600, Spain
Howakai Kuwamizu Hospital
NOT_YET_RECRUITING

Kumamuto-shi, Kumamuto, 862-0954, Japan
Huashan Hospital Fudan University
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200040, China
IRCCS Istituto dell Scienze Neurologiche di Bologna
NOT_YET_RECRUITING

Bologna, 40139, Italy
Inselspital - Universitätsspital Bern
NOT_YET_RECRUITING

Bern, 3010, Switzerland
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING

Daegu, 42601, South Korea
LMU Klinikum der Universität München - Campus Grosshadern
NOT_YET_RECRUITING

Bayern, Muenchen, 81377, Germany
Meris Clinical Research-310 Oakfield Dr
NOT_YET_RECRUITING

Brandon, Florida, 33511, United States
Midwest Center for Sleep Disorders (MWCSD)
NOT_YET_RECRUITING

Lansing, Michigan, 48911, United States
Nanfang Hospital Southern Medical University
NOT_YET_RECRUITING

Guangdong, Guangdong, 510515, China
NeuroTrials Research, Inc
NOT_YET_RECRUITING

Atlanta, Georgia, 30328, United States
New Access Research & Medical Services Inc - Kendall
NOT_YET_RECRUITING

Miami, Florida, 33186, United States
RESM Respiratory and Sleep Medical Care Clinic
NOT_YET_RECRUITING

Yokohama, Kanagawa, 222-0033, Japan
Research Carolina Elite
NOT_YET_RECRUITING

Denver, North Carolina, 28037, United States
Revive Research Institute - Southfield - 23999 Northwestern Hwy
NOT_YET_RECRUITING

Southfield, Michigan, 48075, United States
SDS Clinical Trials, Inc-California-Santa Ana
NOT_YET_RECRUITING

Santa Ana, California, 92705, United States
Seoul National University Bundang Hospital
NOT_YET_RECRUITING

Seongnam-si, Gyeonggi-do, 13620, South Korea
Severance Hospital Yonsei University Health System
NOT_YET_RECRUITING

Seoul, 03722, South Korea
Shandong Provincial Qianfoshan Hospital
NOT_YET_RECRUITING

Jinan, Jinan, 250013, China
Sleep & Alertness Clinic
NOT_YET_RECRUITING

Toronto, Ontario, M5S 3A5, Canada
Sleep Practitioners, LLC
NOT_YET_RECRUITING

Macon, Georgia, 31210, United States
Sleep Therapy and Research Center
NOT_YET_RECRUITING

San Antonio, Texas, 78229, United States
Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
NOT_YET_RECRUITING

Schwerin, 19053, Germany
The Catholic University of Korea, St. Vincent's Hospital
NOT_YET_RECRUITING

Suwon, 16247, South Korea
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
NOT_YET_RECRUITING

Guangzhou, Guangzhou, 510630, China
The First Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Changchun, 130021, China
The Kei-Ai Corporation Aggregate Sapporo Hanazono Hospital
RECRUITING

Sapporo, Hokkaido, 064-0915, Japan
The Second Affiliated Hospital of Nanchang University - Donghu Campus
NOT_YET_RECRUITING

Nanchang, Nanchang, 330006, China
UZ Gent
NOT_YET_RECRUITING

Ghent, 9000, Belgium
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
NOT_YET_RECRUITING

Marburg, 35043, Germany
Vitaly Clinical Research LLC
NOT_YET_RECRUITING

Miami, Florida, 33125, United States
West Ottawa Sleep Center
NOT_YET_RECRUITING

Ottawa, Ontario, K2C 0P7, Canada
Wu Lab at Johns Hopkins University
NOT_YET_RECRUITING

Baltimore, Maryland, 21205, United States
Xuanwu Hospital Capital Medical University
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100053, China

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