Parkinson Disease
Conditions
Keywords
Parkinson's disease (PD), Levodopa, Carbidopa, Motor Fluctuations, Non-Motor Fluctuations, Adjunctive treatment, COMT inhibitor
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
Interventions
DRUGOpicapone
Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period
Sponsors
Neurocrine Biosciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ONGENTYS treatment patterns | 6 months | Reason for initiating treatment and discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-C | 6 months | Clinical Global Impression of Change Scale |
| MDS-UPDRS Parts I, II, and IV | 6 months | Movement Disorder Society-Unified Parkinson's Disease Rating Scale |
| PD Status | 6 months | PD Status Questionnaire |
| PGI-C | 6 months | Patient Global Impression of Change Scale |
| NoMoFa | 6 months | Non-Motor Fluctuation Assessment |
| PDQ-8 | 6 months | Parkinson's Disease Questionnaire-8 |
Countries
United States
Outcome results
None listed