Opicapone Treatment Initiation Open-Label Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-08-04

Brief Summary

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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

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ONGENTYS

Opicapone 50 mg capsule once daily for 6 months

Opicapone

Intervention Type DRUG

Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period

Interventions

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Opicapone

Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period

Intervention Type DRUG

Other Intervention Names

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ONGENTYS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No