Dystonia Clinical Trial
Official title:
Strategy to Adapt Botulinum Toxin Doses in Dystonia
| NCT number | NCT06386848 |
| Other study ID # | 2023PI187 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 1, 2024 |
| Est. completion date | June 1, 2024 |
| Verified date | January 2024 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended. We we ll study the increase of the dose injected over the time, the side effects... The hypothesis is that we inject smaller doses than we could regarding the recommandations
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | June 1, 2024 |
| Est. primary completion date | May 1, 2024 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - patients over 18 years old followed for dystonia and treated with botulinum toxin Exclusion Criteria: - first dose of botulinum toxin not available |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | First dose of botulinum toxin injected, U | dose injected in U | 30 years | |
| Secondary | Effective dose of botulinum toxin | dose injected in U | 30 years | |
| Secondary | Side effects | diplopia, ptosis and others | 30 years |
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