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RECRUITING
NCT07493265
PHASE2

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

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

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 \[MWTs\]).

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-03-26

Completion Date

2027-03-01

Last Updated

2026-05-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

E2086

E2086 oral tablets.

DRUG

Placebo

E2086 matching placebo tablet.

Locations (57)

SDS Clinical Trials, Inc-California-Santa Ana

Santa Ana, California, United States

Meris Clinical Research-310 Oakfield Dr

Brandon, Florida, United States

Hope Research Network Trials -6500 NW 77th CT

Medley, Florida, United States

Vitaly Clinical Research LLC

Miami, Florida, United States

Anchor Medical Research LLC

Miami, Florida, United States

New Access Research & Medical Services Inc - Kendall

Miami, Florida, United States

NeuroTrials Research, Inc

Atlanta, Georgia, United States

Sleep Practitioners, LLC

Macon, Georgia, United States

Clinical Research Institute Stockbridge

Stockbridge, Georgia, United States

Wu Lab at Johns Hopkins University

Baltimore, Maryland, United States

Midwest Center for Sleep Disorders (MWCSD)

Lansing, Michigan, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Revive Research Institute - Southfield - 23999 Northwestern Hwy

Southfield, Michigan, United States

Research Carolina Elite

Denver, North Carolina, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

Future Search Trials of Neurology

Austin, Texas, United States

Sleep Therapy and Research Center

San Antonio, Texas, United States

ANIMA Research Center

Alken, Belgium

UZ Gent

Ghent, Belgium

CaRe Clinic - Calgary - HyperCore - PPDS

Calgary, Alberta, Canada

AMNDX, Inc

Markham, Ontario, Canada

West Ottawa Sleep Center

Ottawa, Ontario, Canada

Centricity Research - CPU - Bayview

Toronto, Ontario, Canada

Sleep & Alertness Clinic

Toronto, Ontario, Canada

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

The First Hospital of Jilin University

Changchun, Changchun, China

Nanfang Hospital Southern Medical University

Guangdong, Guangdong, China

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

Guangzhou, Guangzhou, China

Shandong Provincial Qianfoshan Hospital

Jinan, Jinan, China

The Second Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Nanchang, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Henan Provincial People's Hospital

Zhengzhou, Zhengzhou, China

LMU Klinikum der Universität München - Campus Grosshadern

Bayern, Muenchen, Germany

Alexianer St. Hedwig Kliniken Berlin GmbH

Berlin, Germany

Advanced Sleep Research GmbH

Berlin, Germany

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, Germany

Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, Germany

IRCCS Istituto dell Scienze Neurologiche di Bologna

Bologna, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

The Kei-Ai Corporation Aggregate Sapporo Hanazono Hospital

Sapporo, Hokkaido, Japan

RESM Respiratory and Sleep Medical Care Clinic

Yokohama, Kanagawa, Japan

Howakai Kuwamizu Hospital

Kumamuto-shi, Kumamuto, Japan

Gokeikai Osaka Kaisei Hospital

Oskaka, Osaka, Japan

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

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

Suwon, South Korea

Hospital Universitario de La Ribera

Alzira, Spain

Corporacio Sanitaria Parc Tauli

Barcelona, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Blua Sanitas Valdebebas

Madrid, Spain

Hospital HM Puerta del Sur

Móstoles, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Inselspital - Universitätsspital Bern

Bern, Switzerland