Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525077
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Safety and Efficacy of FT218 in Idiopathic Hypersomnia REVITALYZ
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Placebo-controlled Randomized Withdrawal Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia IH With an Open-Label Safety Extension
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blind placebo-controlled randomized withdrawal multicenter study of the efficacy and safety of FT218 with an open-label safety extension period FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension The study will enroll subjects who are diagnosed with idiopathic hypersomnia Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulantsalerting agents at study entry The estimated total duration of study for each subject is approximately 42 weeks including the open-label safety extension period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None