Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478238
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-08
Brief Title:
Calcium Folinate Treatment of Spastic Paraplegia 56
Sponsor:
Shanghai 6th Peoples Hospital
Organization:
Shanghai 6th Peoples Hospital
Study Overview
Official Title:
A Prospective Single Arm Clinical Trial of Calcium Folinate in the Treatment of Spastic Paraplegia 56
Status:
RECRUITING
Status Verified Date:
2024-06
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:
CFT-SPG56
Brief Summary:
SPG56 is one of the complicated and early-onset HSP subtypes caused by genetic mutations in CYP2U1 So far there is no standardized and specific clinical therapy for SPG56 The goal of this clinical trial is to explore the efficacy and safety of calcium folinate in the treatment of SPG56 patients
This study is prospective open-label and single arm and this trial will last for 6 years A total of 10 patients will participate and they will receive calcium folinate treatment and professional clinical evaluation regularly
This study is prospective open-label and single arm and this trial will last for 6 years A total of 10 patients will participate and they will receive calcium folinate treatment and professional clinical evaluation regularly
Detailed Description:
None
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