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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 1,088
- Locations
- 2
- Primary Endpoint
- Incidence Rate of ADRs Based on Baseline Characteristics of the Participants
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with Parkinson's disease, who are naïve to Equfina
Exclusion Criteria
- •Participants previously treated with Equfina
- •Participants who have contraindications on package insert of Equfina
Arms & Interventions
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.
Intervention: Equfina (Drug)
Outcomes
Primary Outcomes
Incidence Rate of ADRs Based on Baseline Characteristics of the Participants
Time Frame: 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)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported