NCT06478238

Calcium Folinate Treatment of Spastic Paraplegia 56

A Prospective Single Arm Clinical Trial of Calcium Folinate in the Treatment of Spastic Paraplegia 56

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Spastic Paraplegia

Interventions

Type	Name	Description
DRUG	calcium folinate	Intravenous infusion and/or oral therapy

Timeline

• Start date: 2024-07-01
• Primary completion: 2030-05-31
• Completion: 2030-05-31
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: China