A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
NCT Number: NCT06462404
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Narcolepsy Type 1 (NT1)
Interventions: DRUG: E2086|DRUG: E2086 Placebo|DRUG: Active Comparator|DRUG: Active Comparator Placebo
Sponsor: Eisai Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2025-02-14
Locations: Exalt Clinical Research, Inc., Chula Vista, California, 91910, United States|SDS Clinical Trials, Santa Ana, California, 48911, United States|PharmaDev Clinical Research, Miami, Florida, 33126, United States|Neurotrials Research Inc, Atlanta, Georgia, 30328, United States|Sleep Practioners, LLC, Macon, Georgia, 31210, United States|Clinical Research Institute, Stockbridge, Georgia, 30281, United States|Sound Asleep Research, Inc., Lansing, Michigan, 48911, United States|Research Carolina Elite, Denver, North Carolina, 28037, United States|Medical Care Inc., Goldsboro, North Carolina, 27534, United States|Intrepid Research, LLC, Cincinnati, Ohio, 45245, United States|Bogan Sleep Consultants, LLC, Columbia, South Carolina, 29201, United States|Sleep Therapy and Research Center, San Antonio, Texas, 78229, United States|Comprehensive Sleep Medicine Associates, Sugar Land, Texas, 77478, United States|AMDX Inc., Markham, Ontario, L3R 1A3, Canada|Jodha Tishon Inc, Toronto, Ontario, M5S 3A3, Canada

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).

Primary Outcome Measures: 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., 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., 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., 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., 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., At Day 17
Secondary Outcome Measures: 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., 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., 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., Day 1 up to Day 18|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), 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., 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., Baseline up to Day 20|Number of Participants With Markedly Abnormal Electrocardiogram (ECGs) Findings, Baseline up to Day 20|Number of Participants With Markedly Abnormal Electroencephalogram (EEGs) Findings, 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., Baseline up to Day 20|Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1, Days 1, 5, 9, 13 and 17: 0-24 hours post-dose|Tmax: Time to Reach Cmax of E2086 and its Metabolite M1, 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, 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, Days 1, 5, 9, 13 and 17: 0-24 hours post-dose|t½: Terminal Phase Half-life of E2086 and its Metabolite M1, 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., Days 1, 5, 9, 13 and 17: 0-24 hours post-dose