The Effect of Betaine in Refractory Syringomyelia(RS)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fengzeng Jian
RECRUITING
Beijing
Contact Information
Primary
jian fengzeng
jianfengzeng@xwh.ccmu.edu.cn
+861083198899
Backup
chenghua yuan
yuanchenghua@ccmu.edu.cn
+861083198899
Time Frame
Start Date: 2024-03
Estimated Completion Date: 2028-03
Participants
Target number of participants: 30
Treatments
Experimental: betaine
oral betaine
Placebo_comparator: placebo
rice-flour as a placebo
Related Therapeutic Areas
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov