Progressive Supranuclear PalsyAPOPARKANCT04786158
Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)
An observational study of Progressive Supranuclear Palsy and Corticobasal Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Supranuclear Palsy, Corticobasal Degeneration
- What is being tested?
- Apomorphine
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated
Who may be able to join
- PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
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.
- Being tested
- Apomorphine
- Keywords
- pain, quality of life
- Medical subject headings
- Supranuclear Palsy, Progressive, Corticobasal Degeneration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApomorphineDrug
Reporting the effects of subcutaneous apomorphine on pain and on quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of subcutaneous apomorphine on pain
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.
Measured: 6 months
Effects of subcutaneous apomorphine on quality of life
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Dec 2018
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786158
- Sponsor's protocol ID
- CE_20200204_5_CHH
- Acronym
- APOPARKA
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)
- ClinicalTrials.gov ID
- NCT04786158
- Acronym / sponsor ID
- APOPARKA / CE_20200204_5_CHH
- Keywords
- pain, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated
Key inclusion criteria (1 listed)
- PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApomorphineReporting the effects of subcutaneous apomorphine on pain and on quality of life | Drug | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy and Corticobasal Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of subcutaneous apomorphine on pain (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.