Opicapone Treatment Initiation Open-Label Study | NCT04787965

Studies
Opicapone Treatment Initiation Open-Label Study

NCT04787965

Sponsor

Neurocrine Biosciences

Status

Completed

Last Update Posted

Nov 28, 2022Actual

Enrollment

239Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Opicapone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Aug 4, 2022Actual

Completion Date

Aug 4, 2022Actual

First Submitted Date

Mar 4, 2021

First Submission Date that Met QC Criteria

Mar 4, 2021

First Posted Date

Mar 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2022

Last Update Posted Date

Nov 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

239Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONGENTYS		Opicapone 50 mg capsule once daily for 6 months	Drug: Opicapone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opicapone	Drug	Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period	ONGENTYS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ONGENTYS treatment patterns	Reason for initiating treatment and discontinuation	6 months

Secondary Outcomes

Measure	Description	Time Frame
PD Status	PD Status Questionnaire	6 months
CGI-C	Clinical Global Impression of Change Scale	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olga Klepitskaya, MD, FAAN	Neurocrine Biosciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurocrine clinical site		Los Gatos	California	95032	United States
Neurocrine clinical site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26725544	Background	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.
28027332

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases