Wilson DiseaseWDNCT06762509
The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease
An observational study of Wilson Disease, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Wilson Disease
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, #117 Meishan Street, Shushan District Hefei 230037, China
Hefei
About this study
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
- Being tested
- Botulinum toxin type A
- Keywords
- botulinum toxin type A, wilson disease
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local injection of botulinum toxin type A was given at the time of enrollment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dystonia Rating Scale(UDRS)
Unified Dystonia Rating Scale(UDRS),Higher scores mean a worse outcome.
Measured: 4 weeks
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome
Measured: 4 weeks
Numeric Rating Scales(NRS)
Numeric Rating Scales(NRS),Higher scores mean a worse outcome
Measured: 4 weeks
Activity of Daily Living Scale(ADL)
Activity of Daily Living Scale,Higher scores mean a better outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Dec 2016
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Li, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762509
- Sponsor's protocol ID
- BTTA
- Other IDs
- gxgwfx2021028
- Acronym
- WD
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease
- ClinicalTrials.gov ID
- NCT06762509
- Acronym / sponsor ID
- WD / BTTA
- Conditions
- Wilson Disease
- Keywords
- botulinum toxin type A, wilson disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin type A | – | Drug: Botulinum toxin type AEnrolled 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. |
| 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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type ALocal injection of botulinum toxin type A was given at the time of enrollment | Drug | botulinum toxin type A |
Primary outcome
Unified Dystonia Rating Scale(UDRS)
Time frame: 4 weeks
Unified Dystonia Rating Scale(UDRS),Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
Time frame: 4 weeks
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome
Numeric Rating Scales(NRS)
Time frame: 4 weeks
Numeric Rating Scales(NRS),Higher scores mean a worse outcome
Activity of Daily Living Scale(ADL)
Time frame: 4 weeks
Activity of Daily Living Scale,Higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson Disease, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Dystonia Rating Scale(UDRS) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.