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

Completed

• Conditions: Corticobasal Degeneration; Progressive Supranuclear Palsy

• Registration Number: NCT04786158
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, Ile-de-France, France