The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease

Not Applicable

Completed

• Conditions: Wilson Disease
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT06762509
• Lead Sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Brief Summary

In order to expand the treatment of Wilson disease and improve the quality of life of patients with Wilson's disease, the clinical effect of botulinum toxin type A injection on Wilson's disease was discussed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-01
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Status Verified: 2025-01
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Non-Wilson's disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
botulinum toxin type A	Botulinum toxin type A	Enrolled patients were given basic copper discharge treatment, including sodium dimercaptopropyl sulfonate injection, dimercaptosuccinic acid capsules, zinc gluconate tablets, benzoxol hydrochloride tablets, etc. Local injection of botulinum toxin type A was given at the time of enrollment. Placebo Comparator: Control group Arm Description: Enrolled patients were treated with DMPS basic copper expulsion therapy, including sodium dithioglycolate injection, dithioglycolic acid capsules, zinc gluconate tablets, benzoxol hydrochloride tablets, etc.

Primary Outcome Measures

Name	Time	Method
Activity of Daily Living Scale(ADL)	4 weeks	Activity of Daily Living Scale,Higher scores mean a better outcome.
Unified Dystonia Rating Scale(UDRS)	4 weeks	Unified Dystonia Rating Scale(UDRS),Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)	4 weeks	Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome
Numeric Rating Scales(NRS)	4 weeks	Numeric Rating Scales(NRS),Higher scores mean a worse outcome

Trial Locations

Locations (1)

the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, #117 Meishan Street, Shushan District Hefei 230037, China; 🇨🇳 Hefei, China