Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948684
• Other study ID #: CLEA-2021-167
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atypical Parkinsonism
• Dystonia
• Dystonic Disorders
• Parkinson Disease
• Parkinsonian Disorders

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