Opicapone Treatment Initiation Open-Label Study

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Opicapone

• Registration Number: NCT04787965
• Lead Sponsor: Neurocrine Biosciences

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ONGENTYS	Opicapone	Opicapone 50 mg capsule once daily for 6 months

Primary Outcome Measures

Name	Time	Method
ONGENTYS treatment patterns	6 months	Reason for initiating treatment and discontinuation

Secondary Outcome Measures

Name	Time	Method
MDS-UPDRS Parts I, II, and IV	6 months	Movement Disorder Society-Unified Parkinson's Disease Rating Scale
NoMoFa	6 months	Non-Motor Fluctuation Assessment
CGI-C	6 months	Clinical Global Impression of Change Scale
PGI-C	6 months	Patient Global Impression of Change Scale
PD Status	6 months	PD Status Questionnaire
PDQ-8	6 months	Parkinson's Disease Questionnaire-8

Trial Locations

Locations (1)

Neurocrine clinical site; 🇺🇸 Crab Orchard, West Virginia, United States