Opicapone Treatment Initiation Open-Label Study
Completed
Conditions studied: Parkinson Disease
In brief
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 experiencing "off" episodes with motor fluctuations
Key facts
- Study ID
- NCT04787965
- Run by
- Neurocrine Biosciences
- People needed
- 239
- Starts
- 2021-03-01
- Expected to finish
- 2022-08-04
- Last updated by the study team
- 2022-11-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Neurocrine clinical site — Los Gatos, California, United States
- Neurocrine clinical site — Memphis, Tennessee, United States
- Neurocrine clinical site — Christiansburg, Virginia, United States
- Neurocrine clinical site — Norfolk, Virginia, United States
- Neurocrine clinical site — Auburn, Washington, United States
- Neurocrine clinical site — Crab Orchard, West Virginia, United States
Full record on ClinicalTrials.gov
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