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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Thalidomide
DrugThalidomide 50 - 200 mg once at nightime
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: ThalidomideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ASIA Score
American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function， degree of the spinal cord function, motor1-100, sensory 1-224, higher scores mean a better outcome
Time frame
1 day before and 3 days, 3 months after drug treatmentSecondary outcomes
1
syringomyelia remission
syringomyelia remission is defined as ≥ 25% reduction in syringomyelia volume on T2 images at week 12, as compared with that before thalidomide usage
Time frame
1 day before and 3 days, 3 months after drug treatment2
The evoked electromyographic signal (eEMG) potential
The evoked electromyographic signal (eEMG) potential is the standard index
Time frame
1 day before and 3 days, 3 months after drug treatment3
Visual Analog Scale (VAS)
degree of the pain, 1-10, higher scores mean a worse outcome
Time frame
1 day before and 3 days, 3 months after drug treatment4
Klekamp and Sammi syringomyelia scale
for evaluating the spinal cord function, higher scores mean a better outcome
Time frame
1 day before and 3 days, 3 months after drug treatmentSponsors and contacts
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Source ClinicalTrials.gov