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E2086 for Narcolepsy

Phase 1
Recruiting
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 5, 9, 13 and 17: 0-24 hours post-dose

Summary

"This trial aims to test if a new drug, E2086, is effective in treating excessive daytime sleepiness in adults with narcolepsy type 1, by comparing it to a placebo."

Who is the study for?
Adults over 18 with narcolepsy type 1 can join this trial. They must have specific sleep test results showing severe daytime sleepiness and a history of cataplexy. Participants should have regular sleeping hours, a BMI between 18-40, and experience daily periods of extreme need to sleep or napping for at least three months.
What is being tested?
The study tests E2086's effectiveness against placebo in reducing excessive daytime sleepiness in adults with narcolepsy type 1. The Maintenance of Wakefulness Test measures the success of the treatment.
What are the potential side effects?
While not specified here, common side effects for narcolepsy medications may include headache, nausea, dizziness, insomnia, and potential heart issues or mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 5, 9, 13 and 17: 0-24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 5, 9, 13 and 17: 0-24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 13
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 17
MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 5
+2 more
Secondary study objectives
KSS Score for E2086 Versus Placebo
Karolinska Sleepiness Scale (KSS) Score for E2086 Versus Active Comparator
MRp: Metabolite Ratio of AUC(0-inf)
+4 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group II: Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group III: Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group IV: Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + PlaceboExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group V: Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group VI: Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group VII: Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + PlaceboExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group VIII: Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active ComparatorExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group IX: Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active ComparatorExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group X: Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Comparator
2014
Completed Phase 3
~5860
E2086
2023
Completed Phase 1
~60

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Who is running the clinical trial?

Eisai Inc.Lead Sponsor
521 Previous Clinical Trials
159,734 Total Patients Enrolled
~6 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
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