A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
ConditionNarcolepsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEisai Inc.
About this trial
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 criteria
Qualifiers
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
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)
Disqualifiers
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
total abstinence (if it is their preferred and usual lifestyle)
an intrauterine device or intrauterine hormone-releasing system (IUS)
a contraceptive implant
Trial design
Treatments tested in this trial
- E2086
- Placebo
Treatment groups
64 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov