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Clinical trial

Protocol for Study EQF01S: General Drug Use-Results Observational Study of Equfina® TABLETS 50 mg Observational Study on the Incidences of Adverse Drug Reactions in Patients With Parkinson's Disease (Including Patients With Hepatic Impairment)

ID
Name
EQF01S
Description
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina in participants with parkinson's disease (including participants with hepatic impairment).
Trial arms
Trial start
2020-10-14
Estimated PCD
2022-10-13
Trial end
2022-10-13
Status
Completed
Treatment
Equfina
Equfina oral tablets.
Arms:
Equfina
Size
1088
Primary endpoint
Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Up to 24 Weeks
Incidence Rate of ADRs Based on Baseline Characteristics of the Participants
Up to 24 Weeks
Change From Baseline in Symptoms of Parkinson's Disease After the Start of Treatment with Equfina
Baseline, up to Week 24
Eligibility criteria
Inclusion Criteria: 1. Participants with Parkinson's disease, who are naïve to Equfina Exclusion Criteria: 1. Participants previously treated with Equfina 2. Participants who have contraindications on package insert of Equfina
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1088, 'type': 'ACTUAL'}}
Updated at
2022-12-16

1 organization

1 product

1 indication

Organization
Eisai
Product
Equfina
Indication
Parkinson's disease