Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

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

Translate

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NBI-OPC-PD4006

Background Information

Research Question: 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.

Offered At

Inova Medical Group – Neurology
8081 Innovation Park Dr., #900
Fairfax, VA 22031

Eligibility Information

  • Adults ≥ 18 years of age
  • 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

Ineligibility Information

  • 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

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04787965?term=NBI-OPC-PD4006&draw=2&rank=1