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

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Equfina

• Registration Number: NCT04724109
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-10-14
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Primary Completion: 2022-10-13
• Study Completion: 2022-10-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1088

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Equfina	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.

Primary Outcome Measures

Name	Time	Method
Incidence Rate of ADRs Based on Baseline Characteristics of the Participants	Up to 24 Weeks	Factors affecting safety will be investigated. Investigation for any association with various factors are to be performed employing appropriate analytical methods (example, logistic regression analysis). The factors include: gender, age, inpatient/outpatient status, duration of the disease, severity of Parkinson's disease (Hoehn and Yahr scale), presence/absence and details of psychiatric symptoms, severity of hepatic impairment, comorbidities, presence/absence of surgical treatment for Parkinson's disease, presence/absence of comorbid retinal pathology, history of drug allergy, presence/absence of pregnancy/breast-feeding (for females only), and history of smoking.
Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)	Up to 24 Weeks	The numbers of participants based on the types of ADRs and AEs will be calculated. Number of participants with serious ADRs and serious AEs will be calculated. The numbers of participants based on the types of serious ADRs and serious AEs will be calculated.
Change From Baseline in Symptoms of Parkinson's Disease After the Start of Treatment with Equfina	Baseline, up to Week 24	Parkinson's disease motor examination will be performed using Unified Parkinson's Disease Rating Scale (UPDRS) part III, motor signs of parkinson's disease during "ON" time will be evaluated. It contains following items: (1) speech, (2) facial expression, (3) tremor at rest, (4) action or postural tremor of hands, (5) rigidity, (6) finger taps, (7) hand movements, (8) pronation-supinational movements of hands, (9) leg agility, (9) arising from chair, (10) posture, (11) gait, (12) postural stability, (13) body bradykinesia and hypokinesia. Each item is rated on a 5-point likert scale of 0 to 4: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Higher the score the greater will be the severity.

Trial Locations

Locations (2)

Eisai Trial Site 2; 🇯🇵 Osaka, Japan

Eisai Trial Site 1; 🇯🇵 Tokyo, Japan