Opicapone Treatment Initiation Open-Label Study
Sponsor:
Brief Summary:
observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson’s
disease patients experiencing “off” episodes with motor fluctuations
Criteria
– 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 Criteria:
– 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
Locations
- Neurocrine clinical site, Los Gatos, California, United States, 95032
