Actively Recruiting
The Therapeutic Effect of Thalidomide in Syringomyelia
Led by Xuanwu Hospital, Beijing · Updated on 2024-02-20
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Therapeutic Effect of Thalidomide in Syringomyelia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 greater than 12 months
- Routine laboratory tests within normal limits including bilirubin ≤1.0 times upper limit, AST or ALT <1.0 times upper limit, creatinine <1.0 times upper limit, white-cell count ≥4000/mm3, neutrophils ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥110 g/L, and normal PT, APTT, INR
- Ability to understand and willingness to sign written informed consent or have a caregiver who can
- Must be able to swallow tablets
You will not qualify if you...
- Evidence of tumor metastasis, recurrence, or invasion
- History of psychiatric diseases
- History of seizures
- History of arteriosclerotic cardiovascular diseases within 6 months, including stroke, myocardial infarction, unstable angina
- New York Heart Association Grade II or greater congestive heart failure
- Serious and inadequately controlled cardiac arrhythmia
- Significant vascular disease such as moderate or severe carotid stenosis, aortic aneurysm, or history of aortic dissection
- Severe infection
- History of allergy to relevant drugs
- Pregnancy, lactation, or fertility program in the following 12 months
- History or current diagnosis of peripheral nerve disease
- Abnormal liver or renal function
- Active tuberculosis
- Transplanted organs
- Human immunodeficiency virus infection
- Participation in other experimental studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fengzeng Jian
Beijing, Beijing City, China, 100032
Actively Recruiting
Research Team
F
fengzeng jian
CONTACT
C
chenghua yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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