Actively Recruiting
Phase 2 Study to Test the Safety and Effectiveness of E2086 Tablets Compared to Placebo in Adults With Narcolepsy
Led by Eisai Inc. · Updated on 2026-05-14
64
Participants Needed
57
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness EDS. The study focuses on reducing EDS as measured by the Mean Sleep Latency MSL using the first four maintenance of wakefulness tests MWTs. This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 NT1 or type 2 NT2 within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 years or older at the time of informed consent
- NT1 Cohort: Diagnosis of NT1 within the last 10 years confirmed by PSG and MSLT results and clinical history or cerebrospinal fluid orexin-A/hypocretin-1 concentration ≤110 pg/mL
- NT1 Cohort: At least 4 or more episodes of cataplexy per week averaged over 2 weeks confirmed by diary
- NT2 Cohort: Diagnosis of NT2 within the last 10 years confirmed by PSG and MSLT results and clinical history
- Epworth Sleepiness Scale (ESS) score of 10 or higher
- Regular bedtime between 22:00 and 01:00
- Regular waketime between 05:00 and 10:00
- Time in bed between 7 and 9 hours per night
- Diary completion compliance rate of 80% or higher during screening
- Body mass index (BMI) between 18 and less than 35 kg/m² at screening
You will not qualify if you...
- Females who are pregnant or breastfeeding at screening or baseline
- Females of childbearing potential not using a highly effective contraceptive method before and during the study and for 28 days after
- Clinically significant illness or infection requiring medical treatment within 8 or 4 weeks before dosing respectively
- Diseases affecting study outcome including psychiatric, gastrointestinal, liver, kidney, respiratory, endocrine, hematological, neurological, or cardiovascular disorders
- History of surgery affecting drug metabolism or congenital metabolic abnormalities
- Clinically abnormal symptoms or organ impairment requiring treatment at screening or baseline
- Prolonged QTc interval >450 ms or abnormal blood pressure or heart rate outside defined limits
- Lifetime history of suicidal behavior or recent active psychiatric disorders
- Hypersensitivity to study drug or excipients
- Use of St. John's Wort or certain medications affecting metabolism within specified timeframes
- History of drug or alcohol abuse within 2 years or positive drug/alcohol tests at screening
- Use of prohibited medications including anticataplectic, psychostimulants, sleep aids, and CYP3A inhibitors/inducers within specified washout periods
- Planned surgery requiring general, spinal, or epidural anesthesia during the study
- Known HIV positive status or certain viral infections
- Current use of therapies for obstructive sleep apnea
- Symptomatic restless legs syndrome
- Apnea-hypopnea index ≥15 on screening PSG
- Recent participation in other clinical studies or investigational drug use
- Recent blood or plasma donation
- Past participation in orexin agonist studies discontinued due to adverse reactions or inefficacy
Research Team
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Eisai Medical Information
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