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CompletedNCT04787965OPTI-ONUpdated Nov 28, 2022

Opicapone Treatment Initiation Open-Label Study

An observational study in Parkinson Disease, sponsored by Neurocrine Biosciences. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-28.

Sponsored by Neurocrine Biosciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
239
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson's disease (PD)
  • Levodopa
  • Carbidopa
  • Motor Fluctuations
  • Non-Motor Fluctuations
  • Adjunctive treatment
  • COMT inhibitor
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 239 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
239 participants (actual)
Patient registry
No

Groups and cohorts

  • ONGENTYS

    Opicapone 50 mg capsule once daily for 6 months

    Drug: Opicapone

Interventions

  • DrugOpicapone

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

    Also known as: ONGENTYS

06

What researchers measure

Primary outcomes

  1. ONGENTYS treatment patterns

    Reason for initiating treatment and discontinuation

    Time frame: 6 months

Secondary outcomes

  1. PD Status

    PD Status Questionnaire

    Time frame: 6 months

  2. CGI-C

    Clinical Global Impression of Change Scale

    Time frame: 6 months

  3. MDS-UPDRS Parts I, II, and IV

    Movement Disorder Society-Unified Parkinson's Disease Rating Scale

    Time frame: 6 months

  4. PDQ-8

    Parkinson's Disease Questionnaire-8

    Time frame: 6 months

  5. PGI-C

    Patient Global Impression of Change Scale

    Time frame: 6 months

  6. NoMoFa

    Non-Motor Fluctuation Assessment

    Time frame: 6 months

07

Study locations

6 sites
  • Neurocrine clinical site
    Los Gatos, California 95032, United States
  • Neurocrine clinical site
    Memphis, Tennessee 38157, United States
  • Neurocrine clinical site
    Christiansburg, Virginia 24073, United States
  • Neurocrine clinical site
    Norfolk, Virginia 68134, United States
  • Neurocrine clinical site
    Auburn, Washington 98002, United States
  • Neurocrine clinical site
    Crab Orchard, West Virginia 25827, United States
08

References and documents

Publications

  • 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. PubMed 26725544 ↗
  • 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. PubMed 28027332 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04787965
Lead sponsor
Neurocrine Biosciences
Responsible party
Sponsor
First posted
Mar 9, 2021
Start date
Mar 1, 2021
Primary completion
Aug 4, 2022
Completion
Aug 4, 2022
Last update
Nov 28, 2022

Study contacts

Olga Klepitskaya, MD, FAAN
study director · Neurocrine Biosciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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