Evaluating the effects of betaine on syringomyelia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fengzeng Jian
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: jian fengzeng
• Email: jianfengzeng@xwh.ccmu.edu.cn
• Phone: +861083198899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Thalidomide treatment for syringomyelia

  This study is testing if thalidomide can help improve symptoms for people with syringomyelia, a condition that causes fluid-filled cavities in the spinal cord.

  Recruiting Phase 2 Xuanwu Hospital, Beijing · Beijing, Beijing City · NCT06268093

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.