Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT02963350
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2017-07-24
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Multi-national Open-label Program to Provide BMN 190 to Patients Diagnosed With CLN2 Disease
Sponsor:
BioMarin Pharmaceutical
Organization:
Study Overview
Official Title:
A Multicenter, Multi-national Open-label Program to Provide BMN 190 to Patients Diagnosed With CLN2 Disease
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2017-07
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:
* To provide access to BMN 190 to patients with CLN2 disease who cannot participate in a clinical trial.
* To collect additional information on the safety and tolerability of BMN 190 administration in patients with CLN2 disease.
* To collect additional information on the safety and tolerability of BMN 190 administration in patients with CLN2 disease.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: