Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04126005
Status:
RECRUITING
Last Update Posted:
2023-07-12
First Post:
2019-10-10
Brief Title:
Natural History Study of Patients With Canavan Disease CANinform Study
Sponsor:
Aspa Therapeutics
Organization:
Aspa Therapeutics
Study Overview
Official Title:
A Combination Retrospective Medical History and Prospective Observational Study of Patients With Canavan Disease for Assessment of Natural History of Canavan Disease
Status:
RECRUITING
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:
This study uses medical records that allow retrospective data extraction of critical milestone and motor function data In addition prospective assessments collect data relevant to the natural history of Canavan disease in children
Detailed Description:
The CANinform natural history study is the first multinational effort to rigorously gather both retrospective and prospective data from this patient population Data collection includes extraction of retrospective data from medical records of living and deceased patients and collection of prospective longitudinal data from living patients and their parentscaregivers Motor function assessments are performed remotely in the home via video or in the clinic by qualified study team members Families will be invited to attend clinic visits andor will be followed remotely by the clinical site for approximately 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CANinform | OTHER | Aspa Therapeutics | None |