Narcolepsy Clinical Trials

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

Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 \[MWTs\]).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

• NT1 Cohort: Must fulfill Inclusion Criteria 2a and 2b

‣ 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

Locations
United States
California
SDS Clinical Trials, Inc-California-Santa Ana
NOT_YET_RECRUITING
Santa Ana
Florida
Meris Clinical Research-310 Oakfield Dr
NOT_YET_RECRUITING
Brandon
Hope Research Network Trials -6500 NW 77th CT
NOT_YET_RECRUITING
Medley
Anchor Medical Research LLC
NOT_YET_RECRUITING
Miami
New Access Research & Medical Services Inc - Kendall
NOT_YET_RECRUITING
Miami
Vitaly Clinical Research LLC
NOT_YET_RECRUITING
Miami
Georgia
NeuroTrials Research, Inc
NOT_YET_RECRUITING
Atlanta
Sleep Practitioners, LLC
NOT_YET_RECRUITING
Macon
Clinical Research Institute Stockbridge
NOT_YET_RECRUITING
Stockbridge
Maryland
Wu Lab at Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
Michigan
Midwest Center for Sleep Disorders (MWCSD)
NOT_YET_RECRUITING
Lansing
Henry Ford Medical Center - Columbus
NOT_YET_RECRUITING
Novi
Revive Research Institute - Southfield - 23999 Northwestern Hwy
NOT_YET_RECRUITING
Southfield
North Carolina
Research Carolina Elite
NOT_YET_RECRUITING
Denver
South Carolina
Bogan Sleep Consultants, LLC
RECRUITING
Columbia
Texas
Future Search Trials of Neurology
NOT_YET_RECRUITING
Austin
Sleep Therapy and Research Center
NOT_YET_RECRUITING
San Antonio
Other Locations
Belgium
ANIMA Research Center
NOT_YET_RECRUITING
Alken
UZ Gent
NOT_YET_RECRUITING
Ghent
Canada
CaRe Clinic - Calgary - HyperCore - PPDS
NOT_YET_RECRUITING
Calgary
AMNDX, Inc
NOT_YET_RECRUITING
Markham
West Ottawa Sleep Center
NOT_YET_RECRUITING
Ottawa
Centricity Research - CPU - Bayview
NOT_YET_RECRUITING
Toronto
Sleep & Alertness Clinic
NOT_YET_RECRUITING
Toronto
China
Xuanwu Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Nanfang Hospital Southern Medical University
NOT_YET_RECRUITING
Guangdong
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
NOT_YET_RECRUITING
Guangzhou
Shandong Provincial Qianfoshan Hospital
NOT_YET_RECRUITING
Jinan
The Second Affiliated Hospital of Nanchang University - Donghu Campus
NOT_YET_RECRUITING
Nanchang
Huashan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Germany
LMU Klinikum der Universität München - Campus Grosshadern
NOT_YET_RECRUITING
Bayern
Advanced Sleep Research GmbH
NOT_YET_RECRUITING
Berlin
Alexianer St. Hedwig Kliniken Berlin GmbH
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
NOT_YET_RECRUITING
Marburg
Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
NOT_YET_RECRUITING
Schwerin
Italy
IRCCS Istituto dell Scienze Neurologiche di Bologna
NOT_YET_RECRUITING
Bologna
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
NOT_YET_RECRUITING
Pavia
Centro Ricerche Cliniche Di Verona
NOT_YET_RECRUITING
Verona
Japan
Howakai Kuwamizu Hospital
NOT_YET_RECRUITING
Kumamuto-shi
Gokeikai Osaka Kaisei Hospital
NOT_YET_RECRUITING
Oskaka
The Kei-Ai Corporation Aggregate Sapporo Hanazono Hospital
RECRUITING
Sapporo
RESM Respiratory and Sleep Medical Care Clinic
NOT_YET_RECRUITING
Yokohama
Republic of Korea
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam-si
Severance Hospital Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, St. Vincent's Hospital
NOT_YET_RECRUITING
Suwon
Spain
Hospital Universitario de La Ribera
NOT_YET_RECRUITING
Alzira
Corporacio Sanitaria Parc Tauli
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Donostia
NOT_YET_RECRUITING
Donostia / San Sebastian
Hospital Blua Sanitas Valdebebas
NOT_YET_RECRUITING
Madrid
Hospital Ruber Internacional
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
NOT_YET_RECRUITING
Madrid
Hospital HM Puerta del Sur
NOT_YET_RECRUITING
Móstoles
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Switzerland
Inselspital - Universitätsspital Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Eisai Medical Information
esi_medinfo@eisai.com
+1-888-274-2378
Time Frame
Start Date: 2026-03-26
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 64
Treatments
Placebo_comparator: NT1 Participants: Placebo
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.
Experimental: NT1 Participants: E2086
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.
Placebo_comparator: NT2 Participants: Placebo
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.
Experimental: NT2 Participants: E2086
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.
Sponsors
Leads: Eisai Inc.

This content was sourced from clinicaltrials.gov