Status:
COMPLETED
Opicapone Treatment Initiation Open-Label Study
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients expe...
Eligibility Criteria
Inclusion
- Must be able to complete electronic patient-reported outcome instruments
- Parkinson's disease patients experiencing "off" episodes
- Patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ONGENTYS as adjunctive treatment
Exclusion
- Patient is not cognitively able to complete the study requirements
- Patient is not able to complete the study duration of 6 months
- History of moderate or severe hepatic impairment
- Patient has end-stage renal disease
- Concomitant use of non-selective monoamine oxidase (MAO) inhibitor or catechol-O-methyltransferase (COMT) inhibitors (patients entering study may switch from other COMT inhibitors to ONGENTYS)
- History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms
- Currently enrolled in an interventional clinical trial
- Currently or previously received ONGENTYS
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 4 2022
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04787965
Start Date
March 1 2021
End Date
August 4 2022
Last Update
November 28 2022
Active Locations (6)
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1
Neurocrine clinical site
Los Gatos, California, United States, 95032
2
Neurocrine clinical site
Memphis, Tennessee, United States, 38157
3
Neurocrine clinical site
Christiansburg, Virginia, United States, 24073
4
Neurocrine clinical site
Norfolk, Virginia, United States, 68134