Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420297
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-05-07
Brief Title:
OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Sponsor:
ACADIA Pharmaceuticals Inc
Organization:
ACADIA Pharmaceuticals Inc
Study Overview
Official Title:
A Long-term Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
To evaluate long-term safety and tolerability of carbetocin nasal spray 32 mg TID in subjects with PWS
Detailed Description:
This is a long-term OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray 32 mg TID in subjects with PWS Subjects who complete the antecedent double-blind study ACP-101-302 will be invited to participate in the present study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506201-19-00 | CTIS | None | None |