Parkinson Disease Clinical Trial
Official title:
Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism: a Monocentric Cohort Study With Patient Reported Outcome
Verified date | June 2021 |
Source | Hospital Avicenne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP). Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia. The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP. The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.
Status | Completed |
Enrollment | 63 |
Est. completion date | February 11, 2021 |
Est. primary completion date | February 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed Parkinson's disease or Atypical Parkinsonism - Age > 18 years - Reported dystonia - At least 1 injection with Botulinum toxin realized Exclusion Criteria: - Refusal to participate in the study |
Country | Name | City | State |
---|---|---|---|
France | Avicenne Hospital | Bobigny | Seine-Saint-Denis |
Lead Sponsor | Collaborator |
---|---|
Hospital Avicenne | Assistance Publique - Hôpitaux de Paris |
France,
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Rieu I, Degos B, Castelnovo G, Vial C, Durand E, Pereira B, Simonetta-Moreau M, Sangla S, Fluchère F, Guehl D, Burbaud P, Geny C, Gayraud D, Ory-Magne F, Bouhour F, Llinares E, Derost P, Marques A, Durif F. Incobotulinum toxin A in Parkinson's disease with foot dystonia: A double blind randomized trial. Parkinsonism Relat Disord. 2018 Jan;46:9-15. doi: 10.1016/j.parkreldis.2017.10.009. Epub 2017 Oct 19. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparison of the patients' age between PD and AP groups | Age in years of patients from PD and AP groups | Baseline | |
Other | Comparison of the sex-ratio between PD and AP groups | Percentage of female (%) in PD and AP groups | Screening | |
Other | Comparison of the patients' duration of disease between PD and AP groups | Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups | Baseline | |
Other | Comparison of the patients' severity of the disease between PD and AP groups | Severity of the disease in both PD and AP groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease) | Baseline | |
Other | Comparison of the patients' daily need in levodopa between PD and AP groups | Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups | Baseline | |
Other | Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups | Percentage of patients treated with apomorphine (%) in PD and AP groups | Baseline | |
Other | Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups | Percentage of patients treated with deep brain stimulation (%) in PD and AP groups | Baseline | |
Other | Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia | Age in years | Baseline | |
Other | Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia | Percentage of patients treated with deep brain stimulation (%) in both groups | Baseline | |
Other | Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia | Percentage of patients treated with apomorphine (%) in both groups | Baseline | |
Other | Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia | Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups | Baseline | |
Other | Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia | Severity of the disease in both groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease) | Baseline | |
Other | Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia | Duration of the disease (years since diagnosis of AP or PD) of patients | Baseline | |
Other | Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia | Percentage of female (%) | Baseline | |
Other | Comparison of the dystonia's characteristics between PD and AP groups : muscle affected | Muscle affected by dystonia (described with International Anatomical Terminology) | Day 0 | |
Other | Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia | Duration of the dystonia (years since first report of the dystonia) | Day 0 | |
Other | Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose | Dose of BoNT used (in mL) | Day 0 | |
Other | Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT | Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA) | Day 0 | |
Other | Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection | Site of injection (described with International Anatomical Terminology) | Day 0 | |
Other | Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections | Number of injection performed during injection appointment | Day 0 | |
Other | Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance | Usage of ultrasound or electromyography to guide BoNT injection | Day 0 | |
Primary | Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients | Evaluation by the patient of the efficacy of the former injection on an improvement scale ranging from 0 to 100% (minimum value : 0, maximum value : 100, higher scores mean a better outcome) systematically made in routine care during follow up appointment | Up to twelve months | |
Secondary | Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients | Evaluation by the patient of the duration of the period during which symptoms were improved (in weeks) systematically made in routine care during follow up appointment | Up to twelve months |
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