Calcium Folinate Treatment of Spastic Paraplegia 56

Last updated: June 21, 2024
Sponsor: Shanghai 6th People's Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Limb Spasticity

Treatment

calcium folinate

Clinical Study ID

NCT06478238
2024-058-(1)
  • All Genders

Study 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

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 andcomply with the research program.

Exclusion

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, liverdisease, kidney disease, etc. in the past 1 year;

  4. Pregnancy or lactating women or subjects who are unable to use appropriatecontraception during the trial;

  5. Participating in another study drug trial and used the investigational drug in thepast 30 days;

  6. Subjects have poor compliance or other factors that are not suitable forparticipating in the clinical trial.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: calcium folinate
Phase: 1
Study Start date:
July 01, 2024
Estimated Completion Date:
May 31, 2030

Connect with a study center

  • Shanghai 6th People's Hospita

    Shanghai, Shanghai
    China

    Active - Recruiting

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