The Therapeutic Effect of Thalidomide in Syringomyelia

Launched by XUANWU HOSPITAL, BEIJING · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called thalidomide to treat a condition known as syringomyelia, which is when fluid-filled cavities form within the spinal cord and can cause pain and other serious issues. The goal is to see if thalidomide can help improve symptoms for patients who have not had success with other treatments like surgery. Researchers will measure the effectiveness of the treatment by looking for improvements in specific physical functions after 12 weeks of taking thalidomide.

To participate in this study, individuals should be between the ages of 6 and 75 and should have had no success with previous surgical treatments. Participants also need to be able to swallow tablets and must have a life expectancy of at least one year. However, certain health conditions, like severe heart problems or active infections, would prevent someone from joining the trial. If eligible, participants will take thalidomide and will be closely monitored for any side effects or changes in their condition over the study period. This trial is currently recruiting, giving patients a potential new option for managing their symptoms.

Gender

ALL

Eligibility criteria

• 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 drugs;
• • Pregnancy, lactation, or fertility program in the following 12 months;
• • History or current diagnosis of peripheral nerve disease;
• • Abnormal in liver and renal function;
• • Active tuberculosis;
• • Transplanted organs;
• • Human immunodeficiency virus;
• • Participation in other experimental studies.