Actively Recruiting
Calcium Folinate Treatment of Spastic Paraplegia 56
Led by Shanghai 6th People's Hospital · Updated on 2024-06-27
10
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Calcium Folinate Treatment of Spastic Paraplegia 56
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients meet the clinical diagnostic standard of hereditary spastic paraplegia (HSP)
- Spastic paraplegia type 56 (SPG56) diagnosed by CYP2U1 pathogenic mutation
- Patients are willing to participate and able to understand and comply with the study program
You will not qualify if you...
- Allergy to drugs involved in the study
- Other neurological diseases that may affect evaluation of treatment
- Medical conditions such as heart disease, tumor, blood disease, liver disease, kidney disease in the past year
- Pregnancy, lactation, or inability to use appropriate contraception during the trial
- Participation in another investigational drug trial or use of investigational drug in past 30 days
- Poor compliance or other factors making the participant unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai 6th People's Hospita
Shanghai, Shanghai Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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