NCT06478238 Calcium Folinate Treatment of Spastic Paraplegia 56
| NCT ID | NCT06478238 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-07-01 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT06478238 clinical trial?
This trial is open to participants of all sexes, studying Hereditary Spastic Paraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06478238 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06478238 currently recruiting?
Yes, NCT06478238 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai 6th People's Hospital to inquire about joining.
Where is the NCT06478238 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06478238 clinical trial?
NCT06478238 is sponsored by Shanghai 6th People's Hospital. The trial plans to enroll 10 participants.