The Therapeutic Effect of Betaine in Syringomyelia
ConditionSyringomyelia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing
About this trial
Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine 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 betaine 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,
non-effective response to duraplasty and shunting treatment in 12 months prior to study entry.
Estimated life expectancy must be greater than 12 months.
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.
Disqualifiers
Participants have a cardiometabolic disease for which they take prescribed medications
Evidence of tumor metastasis, recurrence, or invasion;
History of psychiatric diseases ;
History of seizures;
Trial design
Design model
Parallel
Treatments tested in this trial
Betaine
Drug50mg/kg for 12 weeks
Placebo
DrugPlacebo
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: betaineExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 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
Electrophysiology results
electromyography and evoked potential; Change of N9-13 From Baseline in Electrophysiology at postoperation
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov