Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358950
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-02
Brief Title:
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 1 ALKS 2680-201
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 2 Parallel-Group Dose-Range-Finding Study with Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects with Narcolepsy Type 1
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Vibrance-1
Brief Summary:
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy sudden loss of muscle control compared to participants taking placebo alone
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