Dystonia; OrofacialrétroBODOMNCT03363113
Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia
An observational study of Dystonia; Orofacial, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonia; Orofacial
- What is being tested?
- Botulinum Toxins
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 12 Jul 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated by botulinum toxin injection for oromandibular dystonia in the Fondation Rothschild (Paris)
Who may be able to join
- Patient suffering from oromandibular dystonia
- Medical follow up in the Fondation Ophtalmologique Rothschild (Paris)
- Treatment by at least one session of botulinum toxin injection
Who cannot join
- Patient cannot assess symptoms improvement using a Likert scale
About this study
Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts
- Conditions
- Dystonia; Orofacial
- Being tested
- Botulinum Toxins
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum ToxinsDrug
Injection of botulinum toxin in the muscles affected by oromandibular dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement score
Likert scale for the assessment of the clinical improvement after treatment
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jan 2016
- Primary completion1 Apr 2016
- Study completion12 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonia; OrofacialStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363113
- Sponsor's protocol ID
- CE_20150630_7_LSM
- Acronym
- rétroBODOM
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 6 Dec 2017
- 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 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia
- ClinicalTrials.gov ID
- NCT03363113
- Acronym / sponsor ID
- rétroBODOM / CE_20150630_7_LSM
- Conditions
- Dystonia; Orofacial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 12 Jul 2016 (actual)
- First posted
- 6 Dec 2017 (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.
Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by botulinum toxin injection for oromandibular dystonia in the Fondation Rothschild (Paris)
Key inclusion criteria (3 listed)
- Patient suffering from oromandibular dystonia
- Medical follow up in the Fondation Ophtalmologique Rothschild (Paris)
- Treatment by at least one session of botulinum toxin injection
Key exclusion criteria (1 listed)
- Patient cannot assess symptoms improvement using a Likert scale
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 ToxinsInjection of botulinum toxin in the muscles affected by oromandibular dystonia | Drug | – |
Primary outcome
Clinical improvement score
Time frame: Two months
Likert scale for the assessment of the clinical improvement after treatment
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 6 Dec 2017.
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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; Orofacial, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 3 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: finished, as of the sponsor's last update on 6 Dec 2017. 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?
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?
Clinical improvement score (time frame: Two months). 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 6 Dec 2017.