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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
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
Research Team
E
Eisai Medical Information
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