Opicapone Treatment Initiation Open-Label Study (OPTI-ON)

Neurocrine Biosciences

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Opicapone

Study type: Observational

Funder types: Industry

Identifiers

NCT04787965

NBI-OPC-PD4006

Details and patient eligibility

About

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

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

239 participants in 1 patient group

ONGENTYS

Description:

Opicapone 50 mg capsule once daily for 6 months

Treatment:

Drug: Opicapone