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

Parkinson Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724109
• Other study ID #: EQF01S
• Status: Completed
• Start date: October 14, 2020
• Est. completion date: October 13, 2022

Study information

• Verified date: December 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1088
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Parkinson Disease

Intervention

Drug:
• Equfina
Equfina oral tablets.

Locations

Country	Name	City	State
Japan	Eisai Trial Site 2	Osaka
Japan	Eisai Trial Site 1	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)	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.	Up to 24 Weeks
Primary	Incidence Rate of ADRs Based on Baseline Characteristics of the Participants	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.	Up to 24 Weeks
Primary	Change From Baseline in Symptoms of Parkinson's Disease After the Start of Treatment with Equfina	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.	Baseline, up to Week 24