A Prospective Single Arm Clinical Trial of Calcium Folinate in the Treatment of Spastic Paraplegia 56
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.
• Patients meet the clinical diagnostic standard of hereditary spastic paraplegia (HSP);
• Spastic paraplegia type 56 (SPG56) was diagnosed by CYP2U1 pathogenic mutation;
• Patients are willing to participate in clinical trials and able to understand and comply with the research program.