A Study to Evaluate the Efficacy, Safety, & Tolerability of E2086 Compared

Clinical Trial 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).

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT04096560` - A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy	Phase 2

See also

Status

Clinical Trial

Phase

Terminated

NCT04096560 - A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06462404
Study type	Interventional
Source	Eisai Inc.
Contact	Eisai Medical Information
Phone	+1-888-274-2378
Email	esi_medinfo@eisai.com
Status	Not yet recruiting
Phase	Phase 1
Start date	June 12, 2024
Completion date	February 14, 2025

A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms