Calcium Folinate Treatment of Spastic Paraplegia 56
ConditionHereditary Spastic Paraplegia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorShanghai 6th People's Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
Patients are allergic to the drugs involved in the study;
Other neurological diseases likely affecting the evaluation of study treatment;
Other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year;
Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial;
Trial design
Treatments tested in this trial
- calcium folinate
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov