Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)

NCT04786158 — Completed, 7 participants, Fondation Ophtalmologique Adolphe de Rothschild

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Registry	NCT04786158, acronym APOPARKA
Status	Completed
Study type	Observational
Enrollment	7 (Actual)
Sponsor	Fondation Ophtalmologique Adolphe de Rothschild (Network)
Conditions	Progressive Supranuclear Palsy, Corticobasal Degeneration
Interventions	Apomorphine (Drug)
Dates	start 2018-12-01, primary completion 2020-06-01, completion 2020-07-01, first posted 2021-03-08, last updated 2021-03-08
Locations	1 site in France

-Summary

Treatment of tauopathies such as Progressive Supranuclear Palsy (PSP) and Cortico Basal Degeneration (CBD) remains a major challenge. These rare severe neurodegenerative extrapyramidal movement disorders share phenotypic overlap and are usually painful. Parkinson disease (PD) is a common extrapyramidal movement disorder and continuous subcutaneous apomorphine infusion (CSAI) is commonly used in advanced PD patients to alleviate motor and non-motor fluctuations. Effects of subcutaneous apomorphine were investigated especially on pain and, on quality of life in 7 patients with PSD or CBD.This is an observational "real life" surveillance-based study.The Verbal Rating Scale for Pain (VRS) was used to assess changes in pain level and the clinical global impression-improvement scale (CGI-I) was used to assess changes in patient's illness before and during six months of treatment. Detailed report of the symptoms and side effects has been recorded by home nurses throughout the study period.

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+Arms and interventions

Apomorphine (Drug): Reporting the effects of subcutaneous apomorphine on pain and on quality of life

+Outcome measures

Primary outcomes

Effects of subcutaneous apomorphine on pain [6 months]: The Verbal Rating Scale for Pain (VRS) was used to assess changes in pain level. The VRS is a five-point scale and consists of a list of adjectives describing various levels of symptom intensity: 0= no itch, 1= mild itch, 2= moderate itch , 3= severe itch and 4=very severe itch. It is used to categorize the itch intensity and features high reliability and concurrent validity. VRS scale was assess before and during six months of treatment.
Effects of subcutaneous apomorphine on quality of life [6 months]: The clinical global impression-improvement scale (CGI-I) was used to assess changes in patient's illness. The CGI-I is a 7 point scale that assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." CGI-I scale was assess before and during six months of treatment.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient under a legal protection procedure
* Patient denying to participated to the study
* Lack of affiliation to a social security system

+Locations (1)

Facility	City	Country	Status
Hôpital Fondation Adolphe de Rothschild	Paris, Île-de-France Region	France