Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462404
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
A Study to Evaluate the Efficacy Safety and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Randomized Double-Blind Single-Dose 5-Period Crossover Study to Evaluate the Efficacy Safety and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Subjects With Narcolepsy Type 1
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None