Calcium folinate treatment for hereditary spastic paraplegia SPG56
A Prospective Single Arm Clinical Trial of Calcium Folinate in the Treatment of Spastic Paraplegia 56
This study is testing if calcium folinate can help people with hereditary spastic paraplegia type 56 feel better over a six-year period.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06478238 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with hereditary spastic paraplegia type 56 due to CYP2U1 mutations.
Not a fit: Patients with other neurological diseases or significant medical conditions that could interfere with the evaluation of the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from SPG56.
How similar studies have performed: There is limited information on similar studies, making this approach relatively novel in the context of SPG56 treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai 6th People's Hospita — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.