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  • Opicapone Treatment Initiation Open-Label Study

Opicapone Treatment Initiation Open-Label Study

Principal Investigator

Henry Moore

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20201264
National Clinical Trials Identifier NCT04787965

Clinical Trial 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 experiencing "off" episodes with motor fluctuations


Phase

Phase IV


Funding Agency/Sponsor

Industry


Disease

Movement Disorders


Enrollment Eligibility

Inclusion 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


Contact Information

Study Contact Wilfredo Rodriguez Somoza
Phone Number +1 (561) 9394169
Email wxr205@miami.edu
Get detailed information on ClinicalTrials.Gov

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