- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786158
Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA) (APOPARKA)
March 5, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ile-de-France
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Paris, Ile-de-France, France, 75019
- Hôpital Fondation Adolphe de Rothschild
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of subcutaneous apomorphine on pain
Time Frame: 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.
|
6 months
|
Effects of subcutaneous apomorphine on quality of life
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
March 8, 2021
Last Update Submitted That Met QC Criteria
March 5, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Tauopathies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Paralysis
- Ophthalmoplegia
- Supranuclear Palsy, Progressive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- CE_20200204_5_CHH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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