Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04239625
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-21
First Post:
2020-01-11
Brief Title:
Open-Label Extension Tolerability and Effects of ALK-001 on Stargardt Disease TEASE
Sponsor:
Alkeus Pharmaceuticals Inc
Organization:
Alkeus Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2 Multicenter Double-Masked Randomized Placebo-Controlled Study to Investigate the Long Term Safety Tolerability Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
Status:
ENROLLING_BY_INVITATION
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 purpose of this open-label multicenter study is to determine the long-term safety pharmacokinetics and effects of ALK-001 C20-D3-retinyl acetate on the progression of Stargardt disease This study is an extension of NCT02402660 and enrolls participants who are at least 8 years old Enrollment is by invitation only
Funding Source - FDA OOPD
Funding Source - FDA OOPD
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01FD006016 | OTHER_GRANT | FDA OOPD | httpsreporternihgovquickSearchR01FD004098 |
| R01FD004098 | FDA | None | None |
| R01FD006316 | FDA | None | None |