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NarcolepsyPhase 2NCT07493265

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

A Phase 2 study testing E2086 in people with Narcolepsy, run by Eisai Inc. at 57 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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]). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Narcolepsy
What is being tested?
E2086
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
57 sitesin 10 countries
Study dates
26 Mar 2026to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 44Show fewer
  • 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
  • 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
  • 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
  • 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
  • Any lifetime history of suicidal behavior as indicated by the C-SSRS
  • Current unstable psychiatric disorder, current active major depressive episode or an active major depressive episode in the past 6 months
  • 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)
  • Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening
  • Hypersensitivity to the study drug or any of the excipients
  • Intake of herbal preparations containing St. John's Wort within 5x the half-life before dosing
  • 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
  • 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
  • Known to be human immunodeficiency virus (HIV) positive
  • Acute Epstein Barr virus (EBV) infection with a positive EBV Viral Capsid Antigen Antibody (VCA) IgM at Baseline
  • 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
  • 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
  • History of formally diagnosed moderate to severe obstructive sleep apnea (OSA)
  • Current use of continuous positive airway pressure (CPAP), hypoglossal nerve stimulator, oral device, or other therapy for the treatment of OSA
  • Symptomatic restless legs syndrome
  • Apnea-hypopnea index >=15 on Screening PSG
  • Use of anticataplectic medications (including but not limited to antidepressants) within 5× the half-life before Screening
  • 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
  • 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
  • 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
  • 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
  • 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
  • Does not agree to abstain from use of recreational drugs during the study
  • 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
  • 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
  • Past participation in a study of an orexin agonist if discontinuation of orexin agonist use was related to an adverse drug reaction or inefficacy

Trial locations and contacts

57 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Eisai Medical Information contact

+1-888-274-2378

esi_medinfo@eisai.com

57 sites in 10 countries

United States17 sites, 17 recruiting

  • NeuroTrials Research, Inc

    Atlanta, Georgia, 30328

    Not yet recruiting

  • Future Search Trials of Neurology

    Austin, Texas, 78731

    Not yet recruiting

  • Wu Lab at Johns Hopkins University

    Baltimore, Maryland, 21205

    Not yet recruiting

  • Meris Clinical Research-310 Oakfield Dr

    Brandon, Florida, 33511

    Not yet recruiting

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201

    Recruiting

  • Research Carolina Elite

    Denver, North Carolina, 28037

    Not yet recruiting

  • Midwest Center for Sleep Disorders (MWCSD)

    Lansing, Michigan, 48911

    Not yet recruiting

  • Sleep Practitioners, LLC

    Macon, Georgia, 31210

    Not yet recruiting

  • Hope Research Network Trials -6500 NW 77th CT

    Medley, Florida, 33166

    Not yet recruiting

  • Vitaly Clinical Research LLC

    Miami, Florida, 33125

    Not yet recruiting

  • Anchor Medical Research LLC

    Miami, Florida, 33176

    Not yet recruiting

  • New Access Research & Medical Services Inc - Kendall

    Miami, Florida, 33186

    Not yet recruiting

  • Henry Ford Medical Center - Columbus

    Novi, Michigan, 48377

    Not yet recruiting

  • Sleep Therapy and Research Center

    San Antonio, Texas, 78229

    Not yet recruiting

  • SDS Clinical Trials, Inc-California-Santa Ana

    Santa Ana, California, 92705

    Not yet recruiting

  • Revive Research Institute - Southfield - 23999 Northwestern Hwy

    Southfield, Michigan, 48075

    Not yet recruiting

  • Clinical Research Institute Stockbridge

    Stockbridge, Georgia, 30291

    Not yet recruiting

Other trials in United States

China8 sites, 8 recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

    Not yet recruiting

  • The First Hospital of Jilin University

    Changchun, Changchun, 130021

    Not yet recruiting

  • Nanfang Hospital Southern Medical University

    Guangdong, Guangdong, 510515

    Not yet recruiting

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

    Guangzhou, Guangzhou, 510630

    Not yet recruiting

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Jinan, 250013

    Not yet recruiting

  • The Second Affiliated Hospital of Nanchang University - Donghu Campus

    Nanchang, Nanchang, 330006

    Not yet recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Zhengzhou, 450003

    Not yet recruiting

Other trials in China

Spain8 sites, 8 recruiting

  • Hospital Universitario de La Ribera

    Alzira, 46600

    Not yet recruiting

  • Corporacio Sanitaria Parc Tauli

    Barcelona, 08208

    Not yet recruiting

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014

    Not yet recruiting

  • Hospital Ruber Internacional

    Madrid, 28034

    Not yet recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Not yet recruiting

  • Hospital Blua Sanitas Valdebebas

    Madrid, 28055

    Not yet recruiting

  • Hospital HM Puerta del Sur

    Móstoles, 28936

    Not yet recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Not yet recruiting

Other trials in Spain

Canada5 sites, 5 recruiting

  • CaRe Clinic - Calgary - HyperCore - PPDS

    Calgary, Alberta, T2N 4L7

    Not yet recruiting

  • AMNDX, Inc

    Markham, Ontario, L3R1A3

    Not yet recruiting

  • West Ottawa Sleep Center

    Ottawa, Ontario, K2C 0P7

    Not yet recruiting

  • Centricity Research - CPU - Bayview

    Toronto, Ontario, M4P 1P2

    Not yet recruiting

  • Sleep & Alertness Clinic

    Toronto, Ontario, M5S 3A5

    Not yet recruiting

Other trials in Canada

Germany5 sites, 5 recruiting

  • LMU Klinikum der Universität München - Campus Grosshadern

    Bayern, Muenchen, 81377

    Not yet recruiting

  • Alexianer St. Hedwig Kliniken Berlin GmbH

    Berlin, 10115

    Not yet recruiting

  • Advanced Sleep Research GmbH

    Berlin, 10117

    Not yet recruiting

  • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

    Marburg, 35043

    Not yet recruiting

  • Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin, 19053

    Not yet recruiting

Other trials in Germany

Japan4 sites, 4 recruiting

  • Howakai Kuwamizu Hospital

    Kumamuto-shi, Kumamuto, 862-0954

    Not yet recruiting

  • Gokeikai Osaka Kaisei Hospital

    Oskaka, Osaka, 532-0003

    Not yet recruiting

  • The Kei-Ai Corporation Aggregate Sapporo Hanazono Hospital

    Sapporo, Hokkaido, 064-0915

    Recruiting

  • RESM Respiratory and Sleep Medical Care Clinic

    Yokohama, Kanagawa, 222-0033

    Not yet recruiting

Other trials in Japan

South Korea4 sites, 4 recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601

    Not yet recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Not yet recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Not yet recruiting

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

    Suwon, 16247

    Not yet recruiting

Other trials in South Korea

Italy3 sites, 3 recruiting

  • IRCCS Istituto dell Scienze Neurologiche di Bologna

    Bologna, 40139

    Not yet recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, 27100

    Not yet recruiting

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134

    Not yet recruiting

Other trials in Italy

Belgium2 sites, 2 recruiting

  • ANIMA Research Center

    Alken, 3570

    Not yet recruiting

  • UZ Gent

    Ghent, 9000

    Not yet recruiting

Other trials in Belgium

Switzerland1 site, 1 recruiting

  • Inselspital - Universitätsspital Bern

    Bern, 3010

    Not yet recruiting

Other trials in Switzerland

About this study

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

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
Being tested
E2086, Placebo
Keywords
Narcolepsy type 1 (NT1), Narcolepsy type 2 (NT2), E2086
Medical subject headings
Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2086Drug

    E2086 oral tablets.

  • PlaceboDrug

    E2086 matching placebo tablet.

Study groups in NCT07493265
Study groupRoleWhat they receive
NT1 Participants: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo
NT1 Participants: E2086ExperimentalParticipants 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.
Receives: Drug: E2086
NT2 Participants: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo
NT2 Participants: E2086ExperimentalParticipants 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.
Receives: Drug: E2086

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and Week 4

Secondary outcomes (14)

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

    WCR assess through participant-reported daily diaries, is a standard measure of cataplexy burden in clinical development programs for narcolepsy treatments, similar in importance to the MWT used for evaluating EDS.

    Measured: At Week 4

  2. 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

    The ESS is a subjective measure of daytime sleepiness. The participant rates on a 4-point Likert scale how likely it is that he/she would doze in 8 different situations. Scoring of the answers is 0 to 3, with 0 being "would never doze" and 3 being "high chance of dozing". The total ESS score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. Scores above 10 are considered indicative of EDS. A decrease from baseline in ESS score represents improvement.

    Measured: Baseline and Week 4

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

    Measured: From first dose of study drug up to Day 113

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

    Laboratory parameters will include hematology, chemistry and urinalysis.

    Measured: Up to Day 113

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

    Vital signs will include measurement of systolic and diastolic blood pressure (BP), heart rate, respiratory rate and body temperature. Any clinically significant change in vital signs will be determined at the investigator's discretion.

    Measured: Up to Day 113

  6. Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters in Participants With NT1 and NT2

    The 12-lead ECG will be evaluated. Any clinically significant change in ECG assessment will be determined at the investigator's discretion.

    Measured: Up to Day 113

  7. Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) in Participants With NT1 and NT2

    Suicidality will be assessed using the C-SSRS. The C-SSRS assesses an individual's degree of suicidality, including suicidal ideation and suicidal behavior. The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behaviour, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behaviour. Any suicidal behaviour is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.

    Measured: Up to Day 113

  8. Mean Change From Baseline in 24-hours Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) up to Week 4 of each dose level in Participants With NT1 and NT2

    The BP will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the measurement of BP recordings after every 24 hours.

    Measured: Baseline and Week 4

  9. Mean Change From Baseline in Day-time and Night-time BP Measured by ABPM in Participants With NT1 and NT2

    The BP will be evaluated by ABPM for all participants based on the measurement of BP recordings after every 24 hours.

    Measured: Baseline and Week 4

  10. Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1

    Measured: Days 28, 63 and 98: 0-24 hours post-dose

  11. Tmax: Time to Reach Cmax of E2086 and its Metabolite M1

    Measured: Days 28, 63 and 98: 0-24 hours post-dose

  12. AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours of E2086 and its Metabolite M1

    Measured: Days 28, 63 and 98: 0-24 hours post-dose

  13. t½: Terminal Phase Half-life of E2086 and its Metabolite M1

    Measured: Days 28, 63 and 98: 0-24 hours post-dose

  14. MRp: Metabolite Ratio of AUC(0-t)

    MRp calculated as ratio of plasma AUC(0-t) of metabolite to parent following molar correction where appropriate. AUC(0-t) is area under the plasma concentration-time curve from zero time to time of last quantifiable concentration of E2086 and its Metabolite M1.

    Measured: Days 28, 63 and 98: 0-24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start26 Mar 2026
  3. Primary completion14 Feb 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493265
Sponsor's protocol ID
E2086-G000-202
Other IDs
2025-523503-30, 2025
Status last verified
Mar 2026
First submitted
20 Mar 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2086 in people with Narcolepsy, run by Eisai Inc. at 57 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, China, Spain, Canada, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eisai Medical Information (+1-888-274-2378, esi_medinfo@eisai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07493265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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