Evaluating the effects of betaine on syringomyelia

The Effect of Betaine in Refractory Syringomyelia（RS）

This study is testing whether betaine can help people with syringomyelia who haven't found relief from other treatments feel better after 12 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06308367 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the therapeutic effects and safety of betaine in patients with refractory syringomyelia, a condition where fluid-filled cavities form within the spinal cord. The study aims to determine if betaine can improve clinical outcomes, specifically measuring changes in the ASIA scale after 12 weeks of treatment. Participants will receive either betaine or a placebo, and the trial will assess the drug's potential role in maintaining osmotic homeostasis in the context of syringomyelia. The study is particularly focused on patients who have not responded to traditional surgical interventions.

Who should consider this trial

Good fit: Ideal candidates include individuals with refractory syringomyelia who are not suitable for duraplasty or shunting due to contraindications or previous treatment failures.

Not a fit: Patients with significant cardiometabolic diseases, psychiatric disorders, or recent serious cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from refractory syringomyelia.

How similar studies have performed: While the specific use of betaine in syringomyelia is novel, similar osmotic agents have shown promise in other neurological conditions.

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.

Where this trial is running

Beijing, Beijing Municipality

• Fengzeng Jian — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: jian fengzeng

Conditions Syringomyelia