The Therapeutic Effect of Thalidomide in Syringomyelia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Thalidomide
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov