Condition or disease | Intervention/treatment |
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Parkinson Disease | Drug: Opicapone Drug: Levodopa (L-DOPA) + Standard care |
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.
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | April 28, 2020 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |
Group/Cohort | Intervention/treatment |
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Cohort 1
Standard of care (including L-DOPA) + starting opicapone
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Drug: Opicapone
Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
Other Name: Ongentys
Drug: Levodopa (L-DOPA) + Standard care Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.
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Cohort 2
Standard of care (including L-DOPA)
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Drug: Levodopa (L-DOPA) + Standard care
Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.
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Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diogo Magalhães, MD | +351 22 986 6100 | diogo.magalhaes@bial.com | |
Contact: Francisco Rocha, BSc | +351 22 986 6100 | francisco.rocha@bial.com |
United Kingdom | |
Norfolk&Norwich University Hospitals | Recruiting |
Norwich, Norfolk, United Kingdom, NR47UY | |
Contact: Rocha Francisco, BSc francisco.rocha@bial.com |
Tracking Information | |||||||||
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First Submitted Date | April 23, 2019 | ||||||||
First Posted Date | May 22, 2019 | ||||||||
Last Update Posted Date | December 31, 2020 | ||||||||
Actual Study Start Date | April 28, 2020 | ||||||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Percentage of patients having at least one Adverse Event (AE) [ Time Frame: through study completion, an average of 1 year ] All AEs reporting
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | ||||||||
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 | ||||||||
Brief 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 | ||||||||
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:
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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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | The study plans to recruit approximately 100 elderly PD patients from neurology clinics | ||||||||
Condition | Parkinson Disease | ||||||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
100 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | July 2022 | ||||||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 75 Years and older (Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03959540 | ||||||||
Other Study ID Numbers | BIA-91067-402 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Bial - Portela C S.A. | ||||||||
Study Sponsor | Bial - Portela C S.A. | ||||||||
Collaborators | Not Provided | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | Bial - Portela C S.A. | ||||||||
Verification Date | December 2020 |