Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05335876
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2022-04-12
Brief Title:
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 IT or OAV101 IV in Clinical Trials
Status:
RECRUITING
Status Verified Date:
2024-05
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:
SPECTRUM
Brief Summary:
This is a global prospective multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial The assessments of safety and efficacy in Study COAV101A12308 will continue for 15 years from the date of OAV101 administration in the previous clinical trial
Detailed Description:
The study is comprised of a Baseline Period and 3 Follow-up Periods Follow-up Periods 1 and 2 consist of in-person visits and Period 3 consists of tele-visits Follow-up Periods 1 and 2 which includes Baseline through Year 5 visits assessments will be performed at the Investigational site During Follow-up Period 3 Year 6 to up to Year 15 after OAV101 administration participantscaregivers will be contacted using tele-visits annually for remote assessments All patients will enter the study at the baseline visit and continue until 15 years since OAV101 administration is reached Total duration of participation in the study will be dependent upon time of enrollment relative to OAV101 administration and will vary by participant
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