Who may be eligible for the Calcium Folinate Treatment of Spastic Paraplegia 56 trial?

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.

ClinicalTrials.gov record NCT06478238

Calcium Folinate Treatment of Spastic Paraplegia 56

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Prospective Single Arm Clinical Trial of Calcium Folinate in the Treatment of Spastic Paraplegia 56

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jun 27, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective, open-label, single-arm Early Phase 1 trial of calcium folinate in people with SPG56 (confirmed CYP2U1 mutation). Ten participants will receive an initial 5-day intravenous course then long-term oral calcium folinate, with regular clinical evaluations. The trial is planned to last six years with major assessments at the end of a five-year follow-up.

What it is studying. The study is testing the safety and efficacy of calcium folinate in people with SPG56. It will measure changes over a five-year follow-up in motor function, spasticity, cognition, laboratory tests (including folate), brain imaging, gait, and high-density EEG.

What the researchers hope to learn. To explore the efficacy and safety of calcium folinate in SPG56 and to document changes from baseline in GMFM-88 (motor function), SPRS (spasticity), MMSE and MoCA (cognition), laboratory indicators (including folate), cranial CT/MRI, gait examination, and high-density EEG over five years.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: calcium folinate

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Patients meet the clinical diagnostic standard of hereditary spastic paraplegia (HSP);
Spastic paraplegia type 56 (SPG56) was diagnosed by CYP2U1 pathogenic mutation;
Patients are willing to participate in clinical trials and able to understand and comply with the research program.

Exclusion criteria

Patients are allergic to the drugs involved in the study;
Other neurological diseases likely affecting the evaluation of study treatment;
Other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year;
Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial;
Participating in another study drug trial and used the investigational drug in the past 30 days;
Subjects have poor compliance or other factors that are not suitable for participating in the clinical trial.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive calcium folinate starting with a 5-day course of intravenous infusions (1 mg/kg/day in two divided doses), then switch to oral dosing (2 mg/kg/day in two daily doses) during hospitalization, followed by long-term oral treatment at 2 mg/kg/day. They will attend regular clinic visits and professional evaluations during long-term follow-up (the registry describes the trial as lasting 6 years), including motor-function and spasticity assessments, cognitive tests, gait examinations, brain CT/MRI, high-density EEG, and laboratory tests (blood chemistry, lipids, folate). Safety and laboratory monitoring will be performed throughout; pregnancy must be avoided and appropriate contraception used if applicable.

How the study is structured. Interventional, open-label, single-group (single-arm) Early Phase 1 treatment study. All participants receive calcium folinate: intravenous infusion 1 mg/kg/day (given in two divided doses) for 5 consecutive days, then oral calcium folinate 2 mg/kg/day given in two daily doses during hospitalization and continued as long-term oral therapy. Planned enrollment is 10 participants. Major outcomes are assessed at the end of a five-year follow-up within a six-year study period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on hereditary spastic paraplegia

Clinical trials21 trials listed for hereditary spastic paraplegiaEvery trial the registry lists for hereditary spastic paraplegia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hereditary spastic paraplegia researchLatest monthly update: September 2026. Includes: SPTSSA treatment signal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jul 1, 2024 (estimated)
Primary completion: May 31, 2030 (estimated)
Study completion: May 31, 2030 (estimated)
Target enrollment: 10 participants (estimated)
Last updated on registry: Jun 27, 2024
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Shanghai 6th People's Hospital
Principal investigator: Li Cao, Head of the Department of Neurology
Shanghai 6th People's Hospital

Participating sites (1)

Shanghai 6th People's HospitaRecruiting
Shanghai, Shanghai Municipality · China
- Shankai Yin · +8664369181 · slxck@126.com

Terms used on this page · explanations by MedicalUpdates.ai

open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single arm: All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
study drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials