DystoniaNCT06386848
Strategy to Adapt Botulinum Toxin Doses in Dystonia
An observational study of Dystonia, run by Central Hospital, Nancy, France.
Trial summary
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... Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonia
- What is being tested?
- Botulinum toxin
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jun 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients over 18 years diagnosed with dystonia
Who may be able to join
- patients over 18 years old followed for dystonia and treated with botulinum toxin
Who cannot join
- first dose of botulinum toxin not available
About this study
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
- Conditions
- Dystonia
- Being tested
- Botulinum toxin
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
Also called onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA
Botulinum toxin doses injected in dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
First dose of botulinum toxin injected, U
dose injected in U
Measured: 30 years
Secondary outcomes (2)
Effective dose of botulinum toxin
dose injected in U
Measured: 30 years
Side effects
diplopia, ptosis and others
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solène FRISMAND, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386848
- Sponsor's protocol ID
- 2023PI187
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy to Adapt Botulinum Toxin Doses in Dystonia
- ClinicalTrials.gov ID
- NCT06386848
- Acronym / sponsor ID
- 2023PI187
- Conditions
- Dystonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 26 Apr 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years diagnosed with dystonia
Key inclusion criteria (1 listed)
- patients over 18 years old followed for dystonia and treated with botulinum toxin
Key exclusion criteria (1 listed)
- first dose of botulinum toxin not available
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 toxinAlso: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinABotulinum toxin doses injected in dystonia | Drug | – |
Primary outcome
First dose of botulinum toxin injected, U
Time frame: 30 years
dose injected in U
2 secondary outcomes
Effective dose of botulinum toxin
Time frame: 30 years
Side effects
Time frame: 30 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
First dose of botulinum toxin injected, U (time frame: 30 years). 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 26 Apr 2024.