Opicapone Treatment Initiation Open-Label Study

Parkinson Disease Clinical Trial

— OPTI-ON  

Official title:

Opicapone Treatment Initiation Open-Label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787965
• Other study ID #: NBI-OPC-PD4006
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: August 4, 2022

Study information

• Verified date: November 2022
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Neurocrine clinical site	Auburn	Washington
United States	Neurocrine clinical site	Christiansburg	Virginia
United States	Neurocrine clinical site	Crab Orchard	West Virginia
United States	Neurocrine clinical site	Los Gatos	California
United States	Neurocrine clinical site	Memphis	Tennessee
United States	Neurocrine clinical site	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016 Feb;15(2):154-165. doi: 10.1016/S1474-4422(15)00336-1. Epub 2015 Dec 23. — View Citation

Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ONGENTYS treatment patterns	Reason for initiating treatment and discontinuation	6 months
Secondary	PD Status	PD Status Questionnaire	6 months
Secondary	CGI-C	Clinical Global Impression of Change Scale	6 months
Secondary	MDS-UPDRS Parts I, II, and IV	Movement Disorder Society-Unified Parkinson's Disease Rating Scale	6 months
Secondary	PDQ-8	Parkinson's Disease Questionnaire-8	6 months
Secondary	PGI-C	Patient Global Impression of Change Scale	6 months
Secondary	NoMoFa	Non-Motor Fluctuation Assessment	6 months