Parkinson DiseaseNCT03959540
Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone
- Type of treatment
- Pill or oral medicine
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Apr 2020to 11 May 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study plans to recruit approximately 100 elderly PD patients from neurology clinics
Who may be able to join
- Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
- Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary [acquired or symptomatic] Parkinsonism, Parkinson-plus syndrome)
- Patient with age >=75 years at enrolment
- Patient with end-of-dose motor fluctuations suitable for additional treatment optimization
Who cannot join
- Patient concurrently participating in any clinical trial
- Patient who used tolcapone or opicapone previously
- For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
- Patient with any contraindications to Ongentys use
- Patient with any concomitant medical condition that could interfere with study assessments
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk&Norwich University Hospitals
Norwich, Norfolk, NR47UY
About this study
Official title: A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting
Read the detailed description
This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment.
PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts:
- Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone
- Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment.
This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.
- Conditions
- Parkinson Disease
- Being tested
- Opicapone, Levodopa (L-DOPA) + Standard care
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpicaponeDrug
Also called Ongentys
Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
Levodopa (L-DOPA) + Standard careDrug
Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Standard of care (including L-DOPA) + starting opicapone Receives: Drug: Opicapone; Drug: Levodopa (L-DOPA) + Standard care | |
| Cohort 2 | Standard of care (including L-DOPA) Receives: Drug: Levodopa (L-DOPA) + Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients having at least one Adverse Event (AE)
All AEs reporting
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Clinical Global Impression of Improvement (CGI-I)
hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).
Measured: at Follow-up visit at 1, 3, 6, 9, 12 months
Parkinson Disease Questionnaire (PDQ-8)
hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).
Measured: at baseline, Follow-up visit at 6,12 months
Unified Parkinson's Disease Rating Scale (UPDRS)
change from baseline at each follow-up visit for each of the 4 sections and for the total score (from 0=no disability to 199=total disability).
Measured: at baseline, Follow-up visit at 6,12 months
Montreal Cognitive Assessment (MoCA)
change from baseline at each follow-up visit (30-point test; score >26 is normal).
Measured: at baseline, Follow-up visit at 6,12 months
Patients' Global Impressions of Change (PGI-C)
Percentage of patients for each item at each follow-up visit (from 1=very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment).
Measured: at Follow-up visit at 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start28 Apr 2020
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959540
- Sponsor's protocol ID
- BIA-91067-402
- Status last verified
- Oct 2021
- First submitted
- 23 Apr 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03959540
- Acronym / sponsor ID
- BIA-91067-402
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 22 May 2019 (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.
The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting
Detailed description
This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment.
PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts:
- Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone
- Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment.
This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Opicapone, Drug: Levodopa (L-DOPA) + Standard careStandard of care (including L-DOPA) + starting opicapone |
| Cohort 2 | – | Drug: Levodopa (L-DOPA) + Standard careStandard of care (including L-DOPA) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study plans to recruit approximately 100 elderly PD patients from neurology clinics
Key inclusion criteria (4 listed)
- Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
- Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary [acquired or symptomatic] Parkinsonism, Parkinson-plus syndrome)
- Patient with age >=75 years at enrolment
- Patient with end-of-dose motor fluctuations suitable for additional treatment optimization
Key exclusion criteria (5 listed)
- Patient concurrently participating in any clinical trial
- Patient who used tolcapone or opicapone previously
- For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
- Patient with any contraindications to Ongentys use
- Patient with any concomitant medical condition that could interfere with study assessments
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 |
|---|---|---|
| OpicaponeAlso: OngentysCapsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision. | Drug | Cohort 1 |
| Levodopa (L-DOPA) + Standard careLevodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Percentage of patients having at least one Adverse Event (AE)
Time frame: through study completion, an average of 1 year
All AEs reporting
5 secondary outcomes
Clinical Global Impression of Improvement (CGI-I)
Time frame: at Follow-up visit at 1, 3, 6, 9, 12 months
Parkinson Disease Questionnaire (PDQ-8)
Time frame: at baseline, Follow-up visit at 6,12 months
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: at baseline, Follow-up visit at 6,12 months
Montreal Cognitive Assessment (MoCA)
Time frame: at baseline, Follow-up visit at 6,12 months
Patients' Global Impressions of Change (PGI-C)
Time frame: at Follow-up visit at 1, 3, 6, 9, 12 months
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 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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 Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United Kingdom.
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 4 inclusion and 5 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 4 Oct 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 United Kingdom. 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?
Percentage of patients having at least one Adverse Event (AE) (time frame: through study completion, an average of 1 year). 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 4 Oct 2021.