Narcolepsy Type 1 (NT1)Phase 1NCT06462404
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
A Phase 1 study testing E2086 and Active Comparator in people with Narcolepsy Type 1 (NT1), run by Eisai Inc. at 14 sites in 2 countries.
Trial summary
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adult participants with narcolepsy type 1 (NT1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy Type 1 (NT1)
- What is being tested?
- E2086 and Active Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 20 Jun 2024to 17 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female, age greater than or equal to (>=) 18 years at the time of informed consent
- Diagnosis of NT1 defined by the following criteria:
- History of daily periods of the irrepressible need to sleep, or daytime lapses into sleep, occurring for at least 3 months
- History of cataplexy (which must be confirmed during the Screening Period by Sleep/Cataplexy Diary)
- At least one of the following:
- On Screening multiple sleep latency test (MSLT): MSL of less than or equal to (<=) 8 minutes and 2 or more sleep onset rapid eye movement periods (SOREMPs) on an MSLT performed according to standard techniques
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- On Screening nocturnal polysomnography (PSG): One or more SOREMPs within 15 minutes of sleep onset
- Epworth Sleepiness Scale score >=10
- Reports regular bedtime, defined as the time that the participant attempts to sleep, between 22:00 and midnight (based on data from the Screening Sleep/Cataplexy 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 Sleep/Cataplexy Diary)
- Reports being in bed between 7 and 9 hours per night (based on data from the Screening Sleep/Cataplexy Diary)
- Body mass index (BMI) >=18 to less than (<) 40 kilograms per meter square (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]), and females who are breastfeeding or pregnant during the Treatment Period. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st 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)
- a nonhormonal intrauterine device (example, "coil") or a progesterone-only intrauterine hormone-releasing system
- a nonsteroidal oral contraceptive (participant must have been on a stable dose of the same nonsteroidal oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 28 days after study drug discontinuation.)
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- depot medroxyprogesterone acetate or depot norethisterone enantate.
- 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 30 days after study drug administration.
- Participants on an oral contraceptive must use an additional barrier method throughout the study and for 30 days after study drug administration.
- 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 are, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above that is, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 92 days after study drug administration. No sperm donation is allowed during the study period and for 92 days after study drug administration
- History of myocardial infarction, ischemic heart disease, or cardiac failure at Screening
- History of clinically significant arrhythmia or uncontrolled arrhythmia
- Known to have or probable positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days of any study visit.
- Exposure within the last 10 days to an individual with confirmed or probable coronavirus disease-2019 (COVID-19) or symptoms within the last 10 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms
- Hypersensitivity to excipients of the study drug (E2086), or to active comparator or any of its excipients
- 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 CSSRS)
- Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS)
- Any history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders), within 10 years of Screening
- Any current psychiatric symptoms as indicated by a standard screening tool (Diagnostic and Statistical Manual of Mental Disorders [DSM-5] Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult)
- Participants with one or more 1st degree (blood) relatives who have lifetime diagnosis of bipolar type I disorder or a psychotic disorder
- Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening
- Evidence of clinically significant disease (examples, allergies; cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
- Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline
- 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.
- History of drug or alcohol dependency or abuse within 2 years before Screening
- Use of illegal recreational drugs at Screening and throughout the study
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
- Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5* the half-life, (whichever is longer) preceding informed consent.
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (examples, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system)
- History of formally diagnosed moderate to severe obstructive sleep apnea, current use of continuous positive airway pressure, or symptomatic restless legs syndrome
- Apnea-hypopnea index >=15 on Screening PSG
- Periodic limb movement arousal index (PLMAI)>=15 on Screening PSG
- Use of anti-cataplectic medications within 5* the half-life before Screening
- Use of psychostimulant medications, prescription and over-the-counter (OTC), within 5*the half-life before Screening
- Examples of prohibited medications include OTC stimulants (example, pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, and pemoline
- Use of sleep promoting medications, prescription and OTC, within 28 days or 5*the half-life before Screening - Examples of prohibited medication include OTC sleep aids, trazodone, hypnotics, benzodiazepines, barbiturates, cannabinoids, and opioids.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Intrepid Research, LLC
Cincinnati, Ohio, 45245
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Research Carolina Elite
Denver, North Carolina, 28037
Medical Care Inc.
Goldsboro, North Carolina, 27534
Advances Repiratory and Sleep Medicine
Greensboro, North Carolina, 27410
Sound Asleep Research, Inc.
Lansing, Michigan, 48911
Sleep Practioners, LLC
Macon, Georgia, 31210
PharmaDev Clinical Research
Miami, Florida, 33126
Sleep Therapy and Research Center
San Antonio, Texas, 78229
SDS Clinical Trials
Santa Ana, California, 48911
Clinical Research Institute
Stockbridge, Georgia, 30281
Comprehensive Sleep Medicine Associates
Sugar Land, Texas, 77478
Canada2 sites
AMDX Inc.
Markham, Ontario, L3R 1A3
Jodha Tishon Inc
Toronto, Ontario, M5S 3A3
About this study
Official title: A Randomized, Double-Blind, Single-Dose, 5-Period Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Subjects With Narcolepsy Type 1
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adult participants with narcolepsy type 1 (NT1).
- Conditions
- Narcolepsy Type 1 (NT1)
- Being tested
- E2086, E2086 Placebo, Active Comparator, Active Comparator Placebo
- Keywords
- Narcolepsy, 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.
E2086 PlaceboDrug
E2086 matching placebo tablet.
Active ComparatorDrug
Active comparator oral tablets.
Active Comparator PlaceboDrug
Active comparator matching placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3 | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active Comparator | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + Placebo | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1 | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2 | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + Placebo | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1 | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2 | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3 | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
| Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active Comparator | Experimental | Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. Receives: Drug: E2086; Drug: E2086 Placebo; Drug: Active Comparator; Drug: Active Comparator Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sleep Latency (MSL) as Assessed by the 4 Maintenance of Wakefulness Tests (MWTs) for E2086 Versus Placebo at Day 1
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of excessive daytime sleepiness (EDS) which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
Measured: At Day 1
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 5
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
Measured: At Day 5
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 9
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
Measured: At Day 9
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 13
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
Measured: At Day 13
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 17
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
Measured: At Day 17
Secondary outcomes (15)
MSL as Assessed by the 4 MWTs for E2086 Versus Active Comparator
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
Measured: Days 1, 5, 9, 13 and 17
Karolinska Sleepiness Scale (KSS) Score for E2086 Versus Active Comparator
The KSS is a subjective measure of an individual's level of sleepiness during the last 10 minutes, as assessed at a particular time of day. The KSS is rated on a 10-point scale, from 1 = extremely alert, to 10 = extremely sleepy, falls asleep all the time. Higher score indicates more sleepiness.
Measured: Day 1 up to Day 18
KSS Score for E2086 Versus Placebo
The KSS is a subjective measure of an individual's level of sleepiness during the last 10 minutes, as assessed at a particular time of day. The KSS is rated on a 10-point scale, from 1 = extremely alert, to 10 = extremely sleepy, falls asleep all the time. Higher score indicates more sleepiness.
Measured: Day 1 up to Day 18
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From first dose of study drug up to Day 20
Number of Participants With Markedly Abnormal Clinical Laboratory Values
Clinical laboratory will include hematology, chemistry, and urinalysis.
Measured: Baseline up to Day 20
Number of Participants With Markedly Abnormal Vital Sign Values
Vital sign parameters will include systolic and diastolic blood pressure, pulse, respiratory rate, body temperature.
Measured: Baseline up to Day 20
Number of Participants With Markedly Abnormal Electrocardiogram (ECGs) Findings
Measured: Baseline up to Day 20
Number of Participants With Markedly Abnormal Electroencephalogram (EEGs) Findings
Measured: Baseline up to Day 20
Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
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 behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, 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: Baseline up to Day 20
Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1
Measured: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
Tmax: Time to Reach Cmax of E2086 and its Metabolite M1
Measured: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration of E2086 and its Metabolite M1
Measured: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Zero Time Extrapolated to Infinite of E2086 and its Metabolite M1
Measured: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
t½: Terminal Phase Half-life of E2086 and its Metabolite M1
Measured: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
MRp: Metabolite Ratio of AUC(0-inf)
MRp will be calculated as ratio of plasma AUC(0-inf) of metabolite to parent following molar correction.
Measured: Days 1, 5, 9, 13 and 17: 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.
- First posted17 Jun 2024
- Study start20 Jun 2024
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1 (NT1)Studies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462404
- Sponsor's protocol ID
- E2086-A001-101
- Status last verified
- May 2025
- First submitted
- 12 Jun 2024
- Last updated
- 4 Jun 2025
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single-Dose, 5-Period Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Subjects With Narcolepsy Type 1
- ClinicalTrials.gov ID
- NCT06462404
- Acronym / sponsor ID
- E2086-A001-101
- Conditions
- Narcolepsy Type 1 (NT1)
- Keywords
- Narcolepsy, E2086
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adult participants with narcolepsy type 1 (NT1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3 | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active Comparator | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + Placebo | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1 | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2 | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + Placebo | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1 | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2 | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3 | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
| Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active Comparator | Experimental | Drug: E2086, Drug: E2086 Placebo, Drug: Active Comparator, Drug: Active Comparator PlaceboParticipants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, age greater than or equal to (>=) 18 years at the time of informed consent
- Diagnosis of NT1 defined by the following criteria:
- Epworth Sleepiness Scale score >=10
- Reports regular bedtime, defined as the time that the participant attempts to sleep, between 22:00 and midnight (based on data from the Screening Sleep/Cataplexy 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 Sleep/Cataplexy Diary)
Key exclusion criteria (38 listed)
- 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]), and females who are breastfeeding or pregnant during the Treatment Period. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st dose of study drug
- Females of childbearing potential who:
- 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 are, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above that is, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 92 days after study drug administration. No sperm donation is allowed during the study period and for 92 days after study drug administration
- History of myocardial infarction, ischemic heart disease, or cardiac failure at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2086E2086 oral tablets. | Drug | Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3, Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active Comparator, Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active Comparator, Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + Placebo, Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1, Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2, Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + Placebo, Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1, Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2, Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3 |
| E2086 PlaceboE2086 matching placebo tablet. | Drug | Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3, Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active Comparator, Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active Comparator, Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + Placebo, Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1, Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2, Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + Placebo, Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1, Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2, Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3 |
| Active ComparatorActive comparator oral tablets. | Drug | Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3, Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active Comparator, Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active Comparator, Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + Placebo, Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1, Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2, Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + Placebo, Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1, Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2, Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3 |
| Active Comparator PlaceboActive comparator matching placebo tablet. | Drug | Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3, Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active Comparator, Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active Comparator, Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + Placebo, Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1, Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2, Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + Placebo, Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1, Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2, Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3 |
Primary outcome
Mean Sleep Latency (MSL) as Assessed by the 4 Maintenance of Wakefulness Tests (MWTs) for E2086 Versus Placebo at Day 1
Time frame: At Day 1
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of excessive daytime sleepiness (EDS) which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 5
Time frame: At Day 5
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 9
Time frame: At Day 9
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 13
Time frame: At Day 13
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 17
Time frame: At Day 17
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of EDS which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will be performed as per the 2021 guidance of the American Academy of Sleep Medicine.
15 secondary outcomes
MSL as Assessed by the 4 MWTs for E2086 Versus Active Comparator
Time frame: Days 1, 5, 9, 13 and 17
Karolinska Sleepiness Scale (KSS) Score for E2086 Versus Active Comparator
Time frame: Day 1 up to Day 18
KSS Score for E2086 Versus Placebo
Time frame: Day 1 up to Day 18
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug up to Day 20
Number of Participants With Markedly Abnormal Clinical Laboratory Values
Time frame: Baseline up to Day 20
Number of Participants With Markedly Abnormal Vital Sign Values
Time frame: Baseline up to Day 20
Number of Participants With Markedly Abnormal Electrocardiogram (ECGs) Findings
Time frame: Baseline up to Day 20
Number of Participants With Markedly Abnormal Electroencephalogram (EEGs) Findings
Time frame: Baseline up to Day 20
Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Day 20
Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1
Time frame: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
Tmax: Time to Reach Cmax of E2086 and its Metabolite M1
Time frame: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration of E2086 and its Metabolite M1
Time frame: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Zero Time Extrapolated to Infinite of E2086 and its Metabolite M1
Time frame: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
t½: Terminal Phase Half-life of E2086 and its Metabolite M1
Time frame: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
MRp: Metabolite Ratio of AUC(0-inf)
Time frame: Days 1, 5, 9, 13 and 17: 0-24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2086 and Active Comparator in people with Narcolepsy Type 1 (NT1), run by Eisai Inc. at 14 sites in 2 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 12 inclusion and 38 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Sleep Latency (MSL) as Assessed by the 4 Maintenance of Wakefulness Tests (MWTs) for E2086 Versus Placebo at Day 1 (time frame: At Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.