NCT06478238 Calcium Folinate Treatment of Spastic Paraplegia 56
| NCT ID | NCT06478238 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2030-05-31 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria: 1. Patients meet the clinical diagnostic standard of hereditary spastic paraplegia (HSP); 2. Spastic paraplegia type 56 (SPG56) was diagnosed by CYP2U1 pathogenic mutation; 3. Patients are willing to participate in clinical trials and able to understand and comply with the research program. Exclusion Criteria: 1. Patients are allergic to the drugs involved in the study; 2. Other neurological diseases likely affecting the evaluation of study treatment; 3. Other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year; 4. Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial; 5. Participating in another study drug trial and used the investigational drug in the past 30 days; 6. Subjects have poor compliance or other factors that are not suitable for participating in the clinical trial.