43-301 : Special Drug Use-Results Survey of ONGENTYS

43-301 : Special Drug Use-Results Survey of ONGENTYS (Long-term observation)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2011210013

Enrollment

250

Registered

2021-05-25

Start date

2021-02-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with intra-day fluctuations of symptom in Parkinson's disease (wearing-off phenomenon) under treatment of combination therapy with levodopa/carbidopa or levodopa/benserazide hydrochloride, for whom ONGENTYS is administrated for the first time

Exclusion criteria

Exclusion criteria: Patients who have received ONGENTYS previously

Design outcomes

Primary

Measure	Time frame
Occurrence status of adverse drug reactions corresponding to specified safety concerns should be investivated. For dyskinesia, the occurrence status should be checked and factors showing the relationship between the occurrence and the administration should be examined. Specified safety concerns: dyskinesia, hallucination/visual hallucination/auditory hallucination/delirium, orthostatic hypotension	—

Measure

Time frame

Occurrence status of adverse drug reactions corresponding to specified safety concerns should be investivated. For dyskinesia, the occurrence status should be checked and factors showing the relationship between the occurrence and the administration should be examined. Specified safety concerns: dyskinesia, hallucination/visual hallucination/auditory hallucination/delirium, orthostatic hypotension

—

Contacts

Public ContactTakafumi Nakao

Ono Pharmaceutical Co.,LTD

pms_contact_ml@ono-pharma.com+81-662225501

Outcome results