Not Yet RecruitingPhase 2

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

64 participantsStarted 2026-03-23

Plain-language 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 \[MWTs\]).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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)

Exclusion criteria

✕. 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:
✕. total abstinence (if it is their preferred and usual lifestyle)
✕. an intrauterine device or intrauterine hormone-releasing system (IUS)
✕. a contraceptive implant
✕. 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
✕. 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

What they're measuring

Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT07493265

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-14

Contact for this trial

Eisai Medical Information

+1-888-274-2378 esi_medinfo@eisai.com

View on ClinicalTrials.gov More Narcolepsy trials