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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04948684
Other study ID # CLEA-2021-167
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date February 11, 2021

Study information

Verified date June 2021
Source Hospital Avicenne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
France Avicenne Hospital Bobigny Seine-Saint-Denis

Sponsors (2)

Lead Sponsor Collaborator
Hospital Avicenne Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (8)

Dressler D. Botulinum toxin drugs: brief history and outlook. J Neural Transm (Vienna). 2016 Mar;123(3):277-9. doi: 10.1007/s00702-015-1478-1. Epub 2015 Nov 11. Review. — View Citation

Giladi N, Meer J, Honigman S. The use of botulinum toxin to treat "striatal" toes. J Neurol Neurosurg Psychiatry. 1994 May;57(5):659. — View Citation

Jankovic J. Botulinum toxin: State of the art. Mov Disord. 2017 Aug;32(8):1131-1138. doi: 10.1002/mds.27072. Epub 2017 Jun 22. Review. — View Citation

Marsili L, Bologna M, Kojovic M, Berardelli A, Espay AJ, Colosimo C. Dystonia in atypical parkinsonian disorders. Parkinsonism Relat Disord. 2019 Sep;66:25-33. doi: 10.1016/j.parkreldis.2019.07.030. Epub 2019 Jul 23. Review. — View Citation

Mills R, Bahroo L, Pagan F. An update on the use of botulinum toxin therapy in Parkinson's disease. Curr Neurol Neurosci Rep. 2015 Jan;15(1):511. doi: 10.1007/s11910-014-0511-3. Review. — View Citation

Pacchetti C, Albani G, Martignoni E, Godi L, Alfonsi E, Nappi G. "Off" painful dystonia in Parkinson's disease treated with botulinum toxin. Mov Disord. 1995 May;10(3):333-6. — View Citation

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

Tolosa E, Compta Y. Dystonia in Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII7-13. Review. — View Citation

Outcome

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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