Clinical trial NCT04787965: Opicapone Treatment Initiation Open-Label Study
Official title: Opicapone Treatment Initiation Open-Label Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson's disease (PD)
Levodopa
Carbidopa
Motor Fluctuations
Non-Motor Fluctuations
Adjunctive treatment
COMT inhibitor
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2021-03-09
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease patients experiencing "off" episodes with motor fluctuations, who are currently being treated by a neurologist and require adjunctive treatment to levodopa/carbidopa

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


Eligibility criteria: 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

Primary outcomes:
measure: ONGENTYS treatment patterns
timeFrame: 6 months
Secondary outcomes:
measure: PD Status
timeFrame: 6 months
measure: CGI-C
timeFrame: 6 months
measure: MDS-UPDRS Parts I, II, and IV
timeFrame: 6 months
measure: PDQ-8
timeFrame: 6 months
measure: PGI-C
timeFrame: 6 months
measure: NoMoFa
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Neurocrine clinical site
state: California
city: Memphis
country: United States
facility: Neurocrine clinical site
state: Tennessee
city: Christiansburg
country: United States
facility: Neurocrine clinical site
state: Virginia
city: Norfolk
country: United States
facility: Neurocrine clinical site
state: Virginia
city: Auburn
country: United States
facility: Neurocrine clinical site
state: Washington
city: Crab Orchard
country: United States
facility: Neurocrine clinical site
state: West Virginia
Study officials:
affiliation: Neurocrine Biosciences
name: Olga Klepitskaya, MD, FAAN
role: STUDY_DIRECTOR
References:
citation: 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.
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.