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A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)

NCT ID: NCT04724109

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1088 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2022-10-13

Brief Summary

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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).

Detailed Description

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Conditions

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Parkinson Disease

Keywords

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Parkinson Disease Parkinsonian Disorders Prospective Non-interventional Hepatic Impairment Equfina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Equfina

Participants with parkinson's disease will be administered Equfina 50 milligram (mg) tablets, orally, once daily in combination with levodopa-containing products. On the basis of symptoms, Equfina 100 mg tablet, orally, once daily may be selected for participants. All the participants will be observed for up to 24 weeks prospectively.

Equfina

Intervention Type DRUG

Equfina oral tablets.

Interventions

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Equfina

Equfina oral tablets.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Trial Site 2

Osaka, , Japan

Site Status

Eisai Trial Site 1

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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EQF01S

Identifier Type: -

Identifier Source: org_study_id