RecruitingPhase 2NCT06268093

The Therapeutic Effect of Thalidomide in Syringomyelia

The Effect of Thalidomide in Refractory Syringomyelia（RS）: a Phase II Clinical Trial

Sponsor

Xuanwu Hospital, Beijing

Enrollment

30 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Thalidomide Syringomyelia

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria16

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.