NCT06308367

The Therapeutic Effect of Betaine in Syringomyelia

The Effect of Betaine in Refractory Syringomyelia（RS）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Syringomyelia

Interventions

Type	Name	Description
DRUG	Betaine	50mg/kg for 12 weeks
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: China