Calcium folinate treatment for hereditary spastic paraplegia SPG56

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of calcium folinate in patients diagnosed with hereditary spastic paraplegia type 56 (SPG56), which is caused by mutations in the CYP2U1 gene. The study is prospective, open-label, and single-arm, involving a total of 10 participants who will receive calcium folinate treatment over a period of 6 years. Regular clinical evaluations will be conducted to monitor the treatment's effects on the patients.

Why it matters

Who can join: the full rules

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 and comply with the research program.

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, liver disease, kidney disease, etc. in the past 1 year;
4. Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial;
5. Participating in another study drug trial and used the investigational drug in the past 30 days;
6. Subjects have poor compliance or other factors that are not suitable for participating in the clinical trial.

Where it's running

• Shanghai 6th People's Hospita
  Shanghai, Shanghai Municipality, China Recruiting

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• Exploring intrathecal baclofen treatment for hereditary spastic paraplegia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.