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COMPLETED 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

NCT06462404 · View on ClinicalTrials.gov ↗

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

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06462404

The ClinicalTrials.gov registry entry for NCT06462404 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06462404 reports 14 study locations spanning 9 distinct geographic areas — top geographies include North Carolina, Georgia, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06462404?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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