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NCT06462404 · ClinicalTrials.gov registry record · Phase 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
A Phase 1 study of Narcolepsy Type 1 (NT1), sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 14
- Study locations
NCT06462404: Completed Phase 1 study of Narcolepsy Type 1 (NT1), sponsored by Eisai.
NCT06462404 is a Phase 1 study of Narcolepsy Type 1 (NT1) that has completed, run by Eisai. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06462404, a Phase 1 study of Narcolepsy Type 1 (NT1), has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 14
- Study locations
Study 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).
Primary Outcome
Sleep latency is defined as the amount of time a person takes to fall asleep. The MWT is an objective assessment of excessive daytime sleepiness (EDS) which consists of measurement tests. A participant undergoes four 40-minute wake trials, where an increased ability to stay awake in the context of trying to remain awake is reflected in a prolonged sleep latency. These measurements of sleep latency at regular intervals across the day are averaged to calculate the mean sleep latency. The MWT will
Conditions Studied
Interventions
- DRUG E2086
- DRUG Active Comparator
- DRUG E2086 Placebo
- DRUG Active Comparator Placebo
Study Locations (14)
North Carolina
- Research Carolina Elite - Denver
- Medical Care Inc. - Goldsboro
- Advances Repiratory and Sleep Medicine - Greensboro
Georgia
- Sleep Practioners, LLC - Macon
- Clinical Research Institute - Stockbridge
Texas
- Sleep Therapy and Research Center - San Antonio
- Comprehensive Sleep Medicine Associates - Sugar Land
Ontario
- AMDX Inc. - Markham
- Jodha Tishon Inc - Toronto
California
- SDS Clinical Trials - Santa Ana
Florida
- PharmaDev Clinical Research - Miami
Michigan
- Sound Asleep Research, Inc. - Lansing
Ohio
- Intrepid Research, LLC - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2025-03-17 |
| Phase | Phase 1 |
What the finished NCT06462404 record still lists
NCT06462404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Narcolepsy Type 1 (NT1) appearing as the primary indexed condition, and to 4 interventions - of which E2086 is the first listed.
NCT06462404 lists 14 locations in 9 states (North Carolina, Georgia, Texas).
Frequently Asked Questions
What is clinical trial NCT06462404 about?
NCT06462404 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1". 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).
What is the current status of trial NCT06462404?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2024-06-20. Estimated completion is 2025-03-17.
What conditions does trial NCT06462404 study?
This clinical trial studies the following conditions: Narcolepsy Type 1 (NT1).
What interventions are being tested in trial NCT06462404?
The interventions under investigation include: E2086 (DRUG), Active Comparator (DRUG), E2086 Placebo (DRUG), Active Comparator Placebo (DRUG).
Who is sponsoring clinical trial NCT06462404?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06462404 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06462404's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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