Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia.
Huimin Chen, Shan Wu, Mingyu Tang...
https://pubmed.ncbi.nlm.nih.gov/37913505Actively Recruiting
Phase 2
Age: 18Years - 80Years
All Genders
ID06268093
The Effect of Thalidomide in Refractory Syringomyelia (RS): a Phase II Clinical Trial
Led by Xuanwu Hospital, Beijing · Updated on 2024-02-20
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating thalidomide as a treatment for refractory syringomyelia, a condition with poorly understood causes and limited effective treatments like duraplasty or shunting. This phase II clinical trial aims to study the indications, therapeutic effects, and side effects of thalidomide, with special attention to its potential role in protecting the blood spinal cord barrier, which may be involved in the disease process. Participants will receive oral thalidomide once nightly at doses ranging from 50 to 200 mg. The study focuses on patients who have not responded to or cannot undergo duraplasty or shunting. The treatment period and follow-up assessments occur at baseline, 3 days, and 3 months after starting the drug to evaluate changes using various clinical scales and tests. During the study, participants will be closely monitored with evaluations of neurological function using the ASIA score and other measures such as syringomyelia remission, electromyographic signals, pain scales, and complication rates. Laboratory tests will be performed to ensure safety, and participants will be followed for at least 12 months to observe the therapeutic effects and any side effects of thalidomide.
CONDITIONS
Brief Title
The Therapeutic Effect of Thalidomide in Syringomyelia
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects
- Non-effective response to duraplasty and shunting treatment in the 12 months before study entry
- Estimated life expectancy greater than 12 months
- Routine lab tests within normal limits for liver, kidney, blood counts, and coagulation
- Ability to understand and willing to sign informed consent, or caregivers who can do so
- Ability 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
- New York Heart Association Grade II or greater congestive heart failure
- Serious and inadequately controlled cardiac arrhythmia
- Significant vascular diseases such as moderate or severe carotid stenosis or aortic aneurysm
- 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
- Organ transplantation
- Human immunodeficiency virus infection
- Participation in other experimental studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration not specified
Participants receive oral Thalidomide once at night to evaluate its therapeutic effects and safety in refractory syringomyelia.
1 baseline visit and 2 follow-up visits (at 3 days and 3 months after treatment)
Trial Site Locations
Total: 1 location
1
Fengzeng Jian
Beijing, Beijing City, China, 100032
Actively Recruiting
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Research Team
F
fengzeng jian
C
chenghua yuan
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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Published Research Related To This Trial
A novel scoring system for assessing adult syringomyelia associated with CM I treatment outcomes.
Jian Guan, Chenghua Yuan, Qingyu Yao...
https://pubmed.ncbi.nlm.nih.gov/37046133Aquaporin-4 expression and blood-spinal cord barrier permeability in canalicular syringomyelia.
Sarah J Hemley, Lynne E Bilston, Shaokoon Cheng...
https://pubmed.ncbi.nlm.nih.gov/23082850Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis.
Chenghua Yuan, Pingchuan Xia, Wanru Duan...
https://pubmed.ncbi.nlm.nih.gov/38014747Cerebrospinal Fluid Hydrodynamics in Chiari I Malformation and Syringomyelia: Modeling Pathophysiology.
John D Heiss
https://pubmed.ncbi.nlm.nih.gov/36424067Intradural Pathology Causing Cerebrospinal Fluid Obstruction in Syringomyelia and Effectiveness of Foramen Magnum and Foramen of Magendie Dredging Treatment.
Jian Guan, Chenghua Yuan, Can Zhang...
https://pubmed.ncbi.nlm.nih.gov/32805463Suppression of TGFβR-Smad3 pathway alleviates the syrinx induced by syringomyelia.
Sumei Liu, Longbing Ma, Boling Qi...
https://pubmed.ncbi.nlm.nih.gov/37248485