Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
Led by Eisai Inc. · Updated on 2026-05-14
64
Participants Needed
57
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness (EDS). The study focuses on reducing EDS as measured by the Mean Sleep Latency (MSL) using the first four maintenance of wakefulness tests (MWTs). This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 (NT1) or type 2 (NT2) within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 years or older at the time of informed consent
- NT1 Cohort: Diagnosis of NT1 within the last 10 years confirmed by PSG and MSLT results and clinical history or cerebrospinal fluid orexin-A/hypocretin-1 concentration ≤110 pg/mL
- NT1 Cohort: At least 4 or more episodes of cataplexy per week averaged over 2 weeks confirmed by diary
- NT2 Cohort: Diagnosis of NT2 within the last 10 years confirmed by PSG and MSLT results and clinical history
- Epworth Sleepiness Scale (ESS) score of 10 or higher
- Regular bedtime between 22:00 and 01:00
- Regular waketime between 05:00 and 10:00
- Time in bed between 7 and 9 hours per night
- Diary completion compliance rate of 80% or higher during screening
- Body mass index (BMI) between 18 and less than 35 kg/m² at screening
You will not qualify if you...
- Females who are pregnant or breastfeeding at screening or baseline
- Females of childbearing potential not using a highly effective contraceptive method before and during the study and for 28 days after
- Clinically significant illness or infection requiring medical treatment within 8 or 4 weeks before dosing respectively
- Diseases affecting study outcome including psychiatric, gastrointestinal, liver, kidney, respiratory, endocrine, hematological, neurological, or cardiovascular disorders
- History of surgery affecting drug metabolism or congenital metabolic abnormalities
- Clinically abnormal symptoms or organ impairment requiring treatment at screening or baseline
- Prolonged QTc interval >450 ms or abnormal blood pressure or heart rate outside defined limits
- Lifetime history of suicidal behavior or recent active psychiatric disorders
- Hypersensitivity to study drug or excipients
- Use of St. John's Wort or certain medications affecting metabolism within specified timeframes
- History of drug or alcohol abuse within 2 years or positive drug/alcohol tests at screening
- Use of prohibited medications including anticataplectic, psychostimulants, sleep aids, and CYP3A inhibitors/inducers within specified washout periods
- Planned surgery requiring general, spinal, or epidural anesthesia during the study
- Known HIV positive status or certain viral infections
- Current use of therapies for obstructive sleep apnea
- Symptomatic restless legs syndrome
- Apnea-hypopnea index ≥15 on screening PSG
- Recent participation in other clinical studies or investigational drug use
- Recent blood or plasma donation
- Past participation in orexin agonist studies discontinued due to adverse reactions or inefficacy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 14 weeks
Participants receive E2086 or placebo tablets orally once daily for 4 weeks during each of the low-, middle-, and high-dose treatment periods, with a washout period of at least 7 days between doses.
3 treatment periods of 4 weeks each with washout intervals
Trial Site Locations
Total: 57 locations
1
SDS Clinical Trials, Inc-California-Santa Ana
Santa Ana, California, United States, 92705
Not Yet Recruiting
2
Meris Clinical Research-310 Oakfield Dr
Brandon, Florida, United States, 33511
Not Yet Recruiting
3
Hope Research Network Trials -6500 NW 77th CT
Medley, Florida, United States, 33166
Not Yet Recruiting
4
Vitaly Clinical Research LLC
Miami, Florida, United States, 33125
Not Yet Recruiting
5
Anchor Medical Research LLC
Miami, Florida, United States, 33176
Not Yet Recruiting
6
New Access Research & Medical Services Inc - Kendall
Miami, Florida, United States, 33186
Not Yet Recruiting
7
NeuroTrials Research, Inc
Atlanta, Georgia, United States, 30328
Not Yet Recruiting
8
Sleep Practitioners, LLC
Macon, Georgia, United States, 31210
Not Yet Recruiting
9
Clinical Research Institute Stockbridge
Stockbridge, Georgia, United States, 30291
Not Yet Recruiting
10
Wu Lab at Johns Hopkins University
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
11
Midwest Center for Sleep Disorders (MWCSD)
Lansing, Michigan, United States, 48911
Not Yet Recruiting
12
Henry Ford Medical Center - Columbus
Novi, Michigan, United States, 48377
Not Yet Recruiting
13
Revive Research Institute - Southfield - 23999 Northwestern Hwy
Southfield, Michigan, United States, 48075
Not Yet Recruiting
14
Research Carolina Elite
Denver, North Carolina, United States, 28037
Not Yet Recruiting
15
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States, 29201
Actively Recruiting
16
Future Search Trials of Neurology
Austin, Texas, United States, 78731
Not Yet Recruiting
17
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229
Not Yet Recruiting
18
ANIMA Research Center
Alken, Belgium, 3570
Not Yet Recruiting
19
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
20
CaRe Clinic - Calgary - HyperCore - PPDS
Calgary, Alberta, Canada, T2N 4L7
Not Yet Recruiting
21
AMNDX, Inc
Markham, Ontario, Canada, L3R1A3
Not Yet Recruiting
22
West Ottawa Sleep Center
Ottawa, Ontario, Canada, K2C 0P7
Not Yet Recruiting
23
Centricity Research - CPU - Bayview
Toronto, Ontario, Canada, M4P 1P2
Not Yet Recruiting
24
Sleep & Alertness Clinic
Toronto, Ontario, Canada, M5S 3A5
Not Yet Recruiting
25
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
Not Yet Recruiting
26
The First Hospital of Jilin University
Changchun, Changchun, China, 130021
Not Yet Recruiting
27
Nanfang Hospital Southern Medical University
Guangdong, Guangdong, China, 510515
Not Yet Recruiting
28
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangzhou, China, 510630
Not Yet Recruiting
29
Shandong Provincial Qianfoshan Hospital
Jinan, Jinan, China, 250013
Not Yet Recruiting
30
The Second Affiliated Hospital of Nanchang University - Donghu Campus
Nanchang, Nanchang, China, 330006
Not Yet Recruiting
31
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
Not Yet Recruiting
32
Henan Provincial People's Hospital
Zhengzhou, Zhengzhou, China, 450003
Not Yet Recruiting
33
LMU Klinikum der Universität München - Campus Grosshadern
Bayern, Muenchen, Germany, 81377
Not Yet Recruiting
34
Alexianer St. Hedwig Kliniken Berlin GmbH
Berlin, Germany, 10115
Not Yet Recruiting
35
Advanced Sleep Research GmbH
Berlin, Germany, 10117
Not Yet Recruiting
36
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Germany, 35043
Not Yet Recruiting
37
Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Germany, 19053
Not Yet Recruiting
38
IRCCS Istituto dell Scienze Neurologiche di Bologna
Bologna, Italy, 40139
Not Yet Recruiting
39
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Italy, 27100
Not Yet Recruiting
40
Centro Ricerche Cliniche Di Verona
Verona, Italy, 37134
Not Yet Recruiting
41
The Kei-Ai Corporation Aggregate Sapporo Hanazono Hospital
Sapporo, Hokkaido, Japan, 064-0915
Actively Recruiting
42
RESM Respiratory and Sleep Medical Care Clinic
Yokohama, Kanagawa, Japan, 222-0033
Not Yet Recruiting
43
Howakai Kuwamizu Hospital
Kumamuto-shi, Kumamuto, Japan, 862-0954
Not Yet Recruiting
44
Gokeikai Osaka Kaisei Hospital
Oskaka, Osaka, Japan, 532-0003
Not Yet Recruiting
45
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Not Yet Recruiting
46
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Not Yet Recruiting
47
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
48
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea, 16247
Not Yet Recruiting
49
Hospital Universitario de La Ribera
Alzira, Spain, 46600
Not Yet Recruiting
50
Corporacio Sanitaria Parc Tauli
Barcelona, Spain, 08208
Not Yet Recruiting
51
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain, 20014
Not Yet Recruiting
52
Hospital Ruber Internacional
Madrid, Spain, 28034
Not Yet Recruiting
53
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Not Yet Recruiting
54
Hospital Blua Sanitas Valdebebas
Madrid, Spain, 28055
Not Yet Recruiting
55
Hospital HM Puerta del Sur
Móstoles, Spain, 28936
Not Yet Recruiting
56
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Not Yet Recruiting
57
Inselspital - Universitätsspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
Research Team
E
Eisai Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here