NCT04787965

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

March 4, 2021

Last Update Submit

November 23, 2022

Conditions

Parkinson Disease

Keywords

Parkinson's disease (PD)LevodopaCarbidopaMotor FluctuationsNon-Motor FluctuationsAdjunctive treatmentCOMT inhibitor

Outcome Measures

Primary Outcomes (1)

  • ONGENTYS treatment patterns

    Reason for initiating treatment and discontinuation

    6 months

Secondary Outcomes (6)

  • PD Status

    6 months

  • CGI-C

    6 months

  • MDS-UPDRS Parts I, II, and IV

    6 months

  • PDQ-8

    6 months

  • PGI-C

    6 months

  • +1 more secondary outcomes

Study Arms (1)

ONGENTYS

Opicapone 50 mg capsule once daily for 6 months

Drug: Opicapone

Interventions

OpicaponeDRUG

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

Also known as: ONGENTYS
ONGENTYS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Neurocrine clinical site

Los Gatos, California, 95032, United States

Location

Neurocrine clinical site

Memphis, Tennessee, 38157, United States

Location

Neurocrine clinical site

Christiansburg, Virginia, 24073, United States

Location

Neurocrine clinical site

Norfolk, Virginia, 68134, United States

Location

Neurocrine clinical site

Auburn, Washington, 98002, United States

Location

Neurocrine clinical site

Crab Orchard, West Virginia, 25827, United States

Location

Related 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.

    PMID: 26725544BACKGROUND

  • 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.

    PMID: 28027332BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Olga Klepitskaya, MD, FAAN

    Neurocrine Biosciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 9, 2021

Study Start

March 1, 2021

Primary Completion

August 4, 2022

Study Completion

August 4, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(6)