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OpenTrials
Completed

NCT Number: NCT04787965

Opicapone Treatment Initiation Open-Label Study

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurocrine clinical site, Los Gatos, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opicapone

Drug

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

Other names: ONGENTYS

Primary outcomes

  1. ONGENTYS treatment patterns

    Time frame: 6 months

    Reason for initiating treatment and discontinuation

Secondary outcomes

  1. PD Status

    Time frame: 6 months

    PD Status Questionnaire

  2. CGI-C

    Time frame: 6 months

    Clinical Global Impression of Change Scale

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

    Time frame: 6 months

    Movement Disorder Society-Unified Parkinson's Disease Rating Scale

  4. PDQ-8

    Time frame: 6 months

    Parkinson's Disease Questionnaire-8

  5. PGI-C

    Time frame: 6 months

    Patient Global Impression of Change Scale

  6. NoMoFa

    Time frame: 6 months

    Non-Motor Fluctuation Assessment

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Acronym: OPTI-ON

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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