RecruitingPhase 2

The Therapeutic Effect of Thalidomide in Syringomyelia

China30 participantsStarted 2024-02

Plain-language summary

Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia. Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects, * or non-effective response to duraplasty and shunting treatment in 12 months prior to study entry. * Estimated life expectancy must be greater than 12 months. * Routine laboratory studies: bilirubin \</=1.0 \* upper limits of normal (ULN); aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)\< 1.0 \* ULN; creatinine \<1.0 \* ULN; white-cell count \>/= 4,000 per cubic millimeter; neutrophils count \>/=1500 per cubic millimeter platelets \>/= 100,000 per cubic millimeter; Hb \>/=110 gram per millilitres; PT, APTT, INR in a normal range. * Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document. * Must be able to swallow tablets Exclusion Criteria: * Evidence of tumor metastasis, recurrence, or invasion; * History of psychiatric diseases ; * History of seizures; * History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months; * New York Heart Association Grade II or greater congestive heart failure; * Serious and inadequately controlled cardiac arrhythmia; * Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection; * Severe infection; * History of allergy to relevant drug…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ASIA Score

Timeframe: 1 day before and 3 days, 3 months after drug treatment

Trial details

NCT IDNCT06268093

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

fengzeng jian

+861083198899 jianfengzeng@xwh.ccmu.edu.cn

View on ClinicalTrials.gov More Syringomyelia trials