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
Qualifiers
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
Treatments tested in this trial
- Betaine
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov