The Therapeutic Effect of Thalidomide in Syringomyelia (NCT06268093) | Clinical Trial Compass
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 range18 Years – 80 Years
SexALL
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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…
What they're measuring
1
ASIA Score
Timeframe: 1 day before and 3 days, 3 months after drug treatment