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

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ClinicalTrials.gov Identifier: NCT04787965
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

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

Condition or disease Intervention/treatment
Parkinson Disease Drug: Opicapone

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opicapone Treatment Initiation Open-Label Study
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Opicapone

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 Name: ONGENTYS




Primary Outcome Measures :
  1. ONGENTYS treatment patterns [ Time Frame: 6 months ]
    Reason for initiating treatment and discontinuation


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04787965


Contacts
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Contact: Cheryl Chen 858-617-7744 cechen@neurocrine.com

Locations
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United States, California
Neurocrine clinical site Recruiting
Los Gatos, California, United States, 95032
United States, Tennessee
Neurocrine clinical site Recruiting
Memphis, Tennessee, United States, 38157
United States, Virginia
Neurocrine clinical site Recruiting
Christiansburg, Virginia, United States, 24073
Neurocrine clinical site Recruiting
Norfolk, Virginia, United States, 68134
United States, Washington
Neurocrine clinical site Recruiting
Auburn, Washington, United States, 98002
United States, West Virginia
Neurocrine clinical site Recruiting
Crab Orchard, West Virginia, United States, 25827
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
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Study Director: Olga Klepitskaya, MD, FAAN Neurocrine Biosciences
Publications:
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT04787965    
Other Study ID Numbers: NBI-OPC-PD4006
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Neurocrine Biosciences:
Parkinson's disease (PD)
Levodopa
Carbidopa
Motor Fluctuations
Non-Motor Fluctuations
Adjunctive treatment
COMT inhibitor
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Opicapone
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents