Actively Recruiting

Early Phase 1
All Genders
NCT06478238

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Shanghai 6th People's Hospita

Shanghai, Shanghai Municipality, China

Actively Recruiting

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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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