The Therapeutic Effect of Betaine in Syringomyelia

Syringomyelia Clinical Trial

Official title: The Effect of Betaine in Refractory Syringomyelia（RS）

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective. Although it is generally thought that syringomyelia is simply an accumulation of CSF from the subarachnoid space, the pathogenesis is likely to be more complex and may involve cellular and molecular processes.

The investigators supposed that betaine might play a key role in the pathogenesis of syringomyelia, especially post-traumatic syringomyelia(PTS), and that betaine, as an Osmotic homeostasis-related drug, would protect Osmotic homeostasis in syringomyelia.

Primary objectives: This clinical trial aims to evaluate the indications, therapeutic effects and safety of betaine in refractory syringomyelia. ;

Related Conditions & MeSH terms

• Syringomyelia

• NCT number: NCT06308367
• Study type: Interventional
• Source: Xuanwu Hospital, Beijing
• Contact: jian fengzeng
• Phone: +861083198899
• Email: jianfengzeng@xwh.ccmu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2024
• Completion date: March 2028