Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268093
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-07
Brief Title:
The Therapeutic Effect of Thalidomide in Syringomyelia
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
The Effect of Thalidomide in Refractory SyringomyeliaRS a Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Purpose This phase II clinical trial aims to evaluate the indications therapeutic effects and side effects of thalidomide in refractory syringomyelia
Primary outcome measure The primary endpoint is the change of ASIA at week 12 The clinical efficacy is defined as ASIA increase 1 at week 12 as compared with that before thalidomide usage
Primary outcome measure The primary endpoint is the change of ASIA at week 12 The clinical efficacy is defined as ASIA increase 1 at week 12 as compared with that before thalidomide usage
Detailed Description:
The pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective Although it is generally thought that syringomyelia is simply an accumulation of CSF from the subarachnoid space the pathogenesis is likely to be more complex and may involve cellular and molecular processes
The investigators supposed that blood spinal cord barrierBSCB might play a key role in the pathogenesis of syringomyelia especially post-traumatic syringomyeliaPTS and that thalidomide as an BSCB protection-related drug would reduce BSCB damage and protect BSCB in syringomyelia
Primary objectives This phase II clinical trial aims to evaluate the indications therapeutic effects and safety of thalidomide in refractory syringomyelia
The investigators supposed that blood spinal cord barrierBSCB might play a key role in the pathogenesis of syringomyelia especially post-traumatic syringomyeliaPTS and that thalidomide as an BSCB protection-related drug would reduce BSCB damage and protect BSCB in syringomyelia
Primary objectives This phase II clinical trial aims to evaluate the indications therapeutic effects and safety of thalidomide in refractory syringomyelia
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