Opicapone Treatment Initiation Open-Label Study (OPTI-ON)

November 23, 2022 updated by: Neurocrine Biosciences
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

239

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Gatos, California, United States, 95032
        • Neurocrine Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38157
        • Neurocrine Clinical Site
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Neurocrine Clinical Site
      • Norfolk, Virginia, United States, 68134
        • Neurocrine Clinical Site
    • Washington
      • Auburn, Washington, United States, 98002
        • Neurocrine Clinical Site
    • West Virginia
      • Crab Orchard, West Virginia, United States, 25827
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ONGENTYS
Opicapone 50 mg capsule once daily for 6 months
Drug: Opicapone
Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period
Other Names:
  • ONGENTYS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Olga Klepitskaya, MD, FAAN, Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

August 4, 2022

Study Completion (Actual)

August 4, 2022

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-OPC-PD4006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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