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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Standard of care (including L-DOPA) + starting opicapone |
| |
| Cohort 2 | Standard of care (including L-DOPA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opicapone | Drug | Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients having at least one Adverse Event (AE) | All AEs reporting | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at Follow-up visit at 1, 3, 6, 9, 12 months |
| Parkinson Disease Questionnaire (PDQ-8) |
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Inclusion Criteria:
Exclusion Criteria:
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The study plans to recruit approximately 100 elderly PD patients from neurology clinics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk&Norwich University Hospitals | Norwich | Norfolk | NR47UY | United Kingdom |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C549349 | opicapone |
| D007980 | Levodopa |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Levodopa (L-DOPA) + Standard care | Drug | Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision. |
|
hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).
| 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). | 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). | 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). | at Follow-up visit at 1, 3, 6, 9, 12 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |