A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
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|ClinicalTrials.gov Identifier: NCT04724109|
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : April 8, 2022
|Condition or disease||Intervention/treatment|
|Parkinson Disease||Drug: Equfina|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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)|
|Actual Study Start Date :||October 14, 2020|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
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 oral tablets.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724109
|Contact: Eisai Inquiry Servicefirstname.lastname@example.org|
|Eisai Trial Site 2||Recruiting|
|Eisai Trial Site 1||Recruiting|