Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02876094
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2016-08-09
Brief Title:
Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy
Sponsor:
Hugh McMillan
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
A Pilot Open-Label Dose Response Study Investigating the Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy SMA
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated Study halted prematurely and will not resume participants are no longer being examined or receiving intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMA
Brief Summary:
Several factors make the use of celecoxib in human SMA patients appealing including 1 low-dosing required for potential therapeutic effect the corresponding dose in humans is much lower than that commonly used in adults and children with 2 favourable side effect profile of this drug particularly at the dosing required 3 the fact that celecoxib crosses the blood brain barrier and 4 demonstration of efficacy in a genetically and pathophysiologically faithful animal mode The investigators therefore believe that celecoxib is a promising disease modifying therapy for SMA
Detailed Description:
This is a pilot open-label dose-response study in patients with SMA type II or III All patients will be treated at each dose of once daily celecoxib 40 80 and 160 mcgkg for a period of two weeks for a total of 6 weeks 42 days of treatment
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