Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02435030
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2015-04-22
Brief Title:
A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C
Sponsor:
ZevraDenmark
Organization:
ZevraDenmark
Study Overview
Official Title:
A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C in Order to Characterise the Individual Patient Disease Profile and Historic Signo-symptomatology Progression Pattern
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This is a prospective non-therapeutic observational study in NP-C patients The aim is to characterize the individual patient disease progression profile through the historical and 6 months prospective evaluation of clinical imaging biologicalbiomarkers and quality of life data
Patients will be offered enrollment into a Phase IIIII study on arimoclomol at the end of the study
Patients will be offered enrollment into a Phase IIIII study on arimoclomol at the end of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-005194-37 | EUDRACT_NUMBER | None | None |