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

NCT07493265 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: E2086-G000-2022025-523503-30
• Study Type: interventional
• Target: 64
• Locations: 10 countries
• Sites: 57

Brief Summary

The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests \[MWTs\]).

Conditions

Narcolepsy

Keywords

Narcolepsy type 1 (NT1); Narcolepsy type 2 (NT2); E2086

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2

  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).

  Baseline and Week 4

Secondary Outcomes (14)

• Weekly Cataplexy Rate (WCR) of E2086 Compared With Placebo at Week 4 in Participants With NT1

  At Week 4

• Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 4 for E2086 Compared With Placebo in Participants With NT1 and NT2

  Baseline and Week 4

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Participants With NT1 and NT2

  From first dose of study drug up to Day 113

• Number of Participants With Markedly Abnormal Laboratory Values in Participants With NT1 and NT2

  Up to Day 113

• Number of Participants With Clinically Significant Changes in Vital Sign Values in Participants With NT1 and NT2

  Up to Day 113

Study Arms (4)

NT1 Participants: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

NT1 Participants: E2086

EXPERIMENTAL

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.

Drug: E2086

NT2 Participants: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

NT2 Participants: E2086

EXPERIMENTAL

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.

Drug: E2086

Interventions

E2086 DRUG

E2086 oral tablets.

NT1 Participants: E2086; NT2 Participants: E2086

Placebo DRUG

E2086 matching placebo tablet.

NT1 Participants: Placebo; NT2 Participants: Placebo

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria to be included in this study:
• Male or female, age greater than or equal to (\>=) 18 years (or as regionally appropriate) at the time of informed consent
• 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)
• 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
• 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
• ESS score \>=10
• 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)
• 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)
• Reports being in bed between 7 and 9 hours per night (based on data from the sleep portion of the Diary)
• Compliance rate \>=80 percentage (%) for completion of the Diary during screening
• Body mass index (BMI) \>=18 to less than (\<) 35 kilograms per square meter (kg/m\^2) at Screening

You may not qualify if:

• 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
• 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:
• total abstinence (if it is their preferred and usual lifestyle)
• an intrauterine device or intrauterine hormone-releasing system (IUS)
• a contraceptive implant
• 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
• 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).
• 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
• 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)
• 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
• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (57)

SDS Clinical Trials, Inc-California-Santa Ana

Santa Ana, California, 92705, United States

NOT YET RECRUITING

Meris Clinical Research-310 Oakfield Dr

Brandon, Florida, 33511, United States

NOT YET RECRUITING

Hope Research Network Trials -6500 NW 77th CT

Medley, Florida, 33166, United States

NOT YET RECRUITING

Vitaly Clinical Research LLC

Miami, Florida, 33125, United States

NOT YET RECRUITING

Anchor Medical Research LLC

Miami, Florida, 33176, United States

NOT YET RECRUITING

New Access Research & Medical Services Inc - Kendall

Miami, Florida, 33186, United States

NOT YET RECRUITING

NeuroTrials Research, Inc

Atlanta, Georgia, 30328, United States

NOT YET RECRUITING

Sleep Practitioners, LLC

Macon, Georgia, 31210, United States

NOT YET RECRUITING

Clinical Research Institute Stockbridge

Stockbridge, Georgia, 30291, United States

NOT YET RECRUITING

Wu Lab at Johns Hopkins University

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

Midwest Center for Sleep Disorders (MWCSD)

Lansing, Michigan, 48911, United States

NOT YET RECRUITING

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

NOT YET RECRUITING

Revive Research Institute - Southfield - 23999 Northwestern Hwy

Southfield, Michigan, 48075, United States

NOT YET RECRUITING

Research Carolina Elite

Denver, North Carolina, 28037, United States

NOT YET RECRUITING

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

RECRUITING

Future Search Trials of Neurology

Austin, Texas, 78731, United States

NOT YET RECRUITING

Sleep Therapy and Research Center

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

ANIMA Research Center

Alken, 3570, Belgium

NOT YET RECRUITING

UZ Gent

Ghent, 9000, Belgium

NOT YET RECRUITING

CaRe Clinic - Calgary - HyperCore - PPDS

Calgary, Alberta, T2N 4L7, Canada

NOT YET RECRUITING

AMNDX, Inc

Markham, Ontario, L3R1A3, Canada

NOT YET RECRUITING

West Ottawa Sleep Center

Ottawa, Ontario, K2C 0P7, Canada

NOT YET RECRUITING

Centricity Research - CPU - Bayview

Toronto, Ontario, M4P 1P2, Canada

NOT YET RECRUITING

Sleep & Alertness Clinic

Toronto, Ontario, M5S 3A5, Canada

NOT YET RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Changchun, 130021, China

NOT YET RECRUITING

Nanfang Hospital Southern Medical University

Guangdong, Guangdong, 510515, China

NOT YET RECRUITING

The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

Guangzhou, Guangzhou, 510630, China

NOT YET RECRUITING

Shandong Provincial Qianfoshan Hospital

Jinan, Jinan, 250013, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Nanchang, 330006, China

NOT YET RECRUITING

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Zhengzhou, 450003, China

NOT YET RECRUITING

LMU Klinikum der Universität München - Campus Grosshadern

Bayern, Muenchen, 81377, Germany

NOT YET RECRUITING

Alexianer St. Hedwig Kliniken Berlin GmbH

Berlin, 10115, Germany

NOT YET RECRUITING

Advanced Sleep Research GmbH

Berlin, 10117, Germany

NOT YET RECRUITING

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, 35043, Germany

NOT YET RECRUITING

Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, 19053, Germany

NOT YET RECRUITING

IRCCS Istituto dell Scienze Neurologiche di Bologna

Bologna, 40139, Italy

NOT YET RECRUITING

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100, Italy

NOT YET RECRUITING

Centro Ricerche Cliniche Di Verona

Verona, 37134, Italy

NOT YET RECRUITING

The Kei-Ai Corporation Aggregate Sapporo Hanazono Hospital

Sapporo, Hokkaido, 064-0915, Japan

RECRUITING

RESM Respiratory and Sleep Medical Care Clinic

Yokohama, Kanagawa, 222-0033, Japan

NOT YET RECRUITING

Howakai Kuwamizu Hospital

Kumamuto-shi, Kumamuto, 862-0954, Japan

NOT YET RECRUITING

Gokeikai Osaka Kaisei Hospital

Oskaka, Osaka, 532-0003, Japan

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

NOT YET RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

NOT YET RECRUITING

The Catholic University of Korea, St. Vincent's Hospital

Suwon, 16247, South Korea

NOT YET RECRUITING

Hospital Universitario de La Ribera

Alzira, 46600, Spain

NOT YET RECRUITING

Corporacio Sanitaria Parc Tauli

Barcelona, 08208, Spain

NOT YET RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, 20014, Spain

NOT YET RECRUITING

Hospital Ruber Internacional

Madrid, 28034, Spain

NOT YET RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Blua Sanitas Valdebebas

Madrid, 28055, Spain

NOT YET RECRUITING

Hospital HM Puerta del Sur

Móstoles, 28936, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

NOT YET RECRUITING

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378; esi_medinfo@eisai.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 25, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (8); DE (5); JP (4); IT (3); BE (2); CA (5); US (17); ES (8); CH (1); KR (4)