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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
E2086
DrugE2086 oral tablets.
Placebo
DrugE2086 matching placebo tablet.
Treatment groups
64 Participants
are divided into 4 treatment groupsGroup A: NT1 Participants: PlaceboPlacebo comparator 1 intervention
Group B: NT1 Participants: E2086Experimental treatment 1 intervention
Group C: NT2 Participants: PlaceboPlacebo comparator 1 intervention
Group D: NT2 Participants: E2086Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Baseline and Week 4Secondary outcomes
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.
Time frame
At Week 42
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.
Time frame
Baseline and Week 43
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Participants With NT1 and NT2
Time frame
From first dose of study drug up to Day 1134
Number of Participants With Markedly Abnormal Laboratory Values in Participants With NT1 and NT2
Laboratory parameters will include hematology, chemistry and urinalysis.
Time frame
Up to Day 113 Source ClinicalTrials.gov