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 States22 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 range18 Years
SexALL
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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)
✓. 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
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
✕. 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