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

NCT06762509 | Completed

• 2 other identifiers: BTTAgxgwfx2021028
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wilson Disease

Keywords

botulinum toxin type A; wilson disease

Outcome Measures

Primary Outcomes (4)

• Unified Dystonia Rating Scale(UDRS)

  Unified Dystonia Rating Scale(UDRS),Higher scores mean a worse outcome.

  4 weeks

• Unified Wilson's Disease Rating Scale(UWDRS)

  Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome

  4 weeks

• Numeric Rating Scales(NRS)

  Numeric Rating Scales(NRS),Higher scores mean a worse outcome

  4 weeks

• Activity of Daily Living Scale(ADL)

  Activity of Daily Living Scale,Higher scores mean a better outcome.

  4 weeks

Study Arms (2)

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

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.

Interventions

Botulinum toxin type A DRUG

Local injection of botulinum toxin type A was given at the time of enrollment

botulinum toxin type A

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine: lead

Study Sites (1)

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

Hefei, China

Location

MeSH Terms

Conditions

Hepatolenticular Degeneration

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: December 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

CN (1)