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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 is a Phase 1 study of Narcolepsy Type 1 (NT1) that has completed, run by Eisai. The registered enrollment target is 22 participants. The trial reports 14 study locations across 9 states.

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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).

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

FieldValue
Enrollment Target 22 participants
Start Date 2024-06-20
Est. Completion 2025-03-17
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT06462404

The ClinicalTrials.gov registry entry for NCT06462404 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.