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

January 13, 2025 updated by: Jun Li, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria：1.Conform to the diagnosis of "2012 European Liver Study Guidelines for Diagnosis and Treatment of hepatolenticular degeneration". 2. Aged from 15 to 65 years.

Exclusion Criteria:Non-Wilson's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Botulinum toxin type A
Local injection of botulinum toxin type A was given at the time of enrollment
Enrolled patients were treated with DMPS basic copper expulsion therapy
Enrolled patients were treated with DMPS basic copper expulsion therapy, including sodium dithioglycolate injection, dithioglycolic acid capsules, zinc gluconate tablets, benzoxol hydrochloride tablets, etc.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTTA
  • gxgwfx2021028 (Other Grant/Funding Number: Department of education, Anhui Province)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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