The Therapeutic Effect of Betaine in Syringomyelia

Launched by XUANWU HOSPITAL, BEIJING · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called betaine to see if it can help people with a condition called syringomyelia, which is often difficult to treat. The main goal is to find out if betaine can improve patients' symptoms over a 12-week period. Researchers will check how much participants' symptoms improve using a scale called ASIA, where a change of 1 point or more is considered a positive response.

To be eligible for the trial, participants should be between the ages of 18 and 74 and have not had success with other treatments like surgery within the last year. They should also be able to swallow tablets and have a life expectancy of more than 12 months. However, people with certain health issues, like heart problems or severe infections, or those who are pregnant or breastfeeding, cannot participate. If you decide to join, you’ll be closely monitored during the study to see how well the treatment works and if there are any side effects. This trial is currently looking for participants, and your involvement could contribute to important research in treating syringomyelia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Must be able to swallow tablets
• Exclusion Criteria:
• • 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;
• • 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 drugs;
• • Pregnancy, lactation, or fertility program in the following 12 months;
• • History or current diagnosis of peripheral nerve disease;
• • Abnormal in liver and renal function;
• • Active tuberculosis;
• • Transplanted organs;
• • Human immunodeficiency virus;
• • Participation in other experimental studies.