A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Activ… (NCT06462404) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
United States, Canada22 participantsStarted 2024-06-20
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
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 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)
. Reports being in bed between 7 and 9 hours per night (based on data from the Screening Sleep/Cataplexy Diary)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Sleep Latency (MSL) as Assessed by the 4 Maintenance of Wakefulness Tests (MWTs) for E2086 Versus Placebo at Day 1
Timeframe: At Day 1
2
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 5
Timeframe: At Day 5
3
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 9
Timeframe: At Day 9
4
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 13
Timeframe: At Day 13
5
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 17
. Body mass index (BMI) \>=18 to less than (\<) 40 kilograms per meter square (kg/m\^2), at Screening
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 \[or hCG\]), 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:
. 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