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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)

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ClinicalTrials.gov Identifier: NCT04724109
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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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).

Condition or disease Intervention/treatment
Parkinson Disease Drug: Equfina

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Equfina
Equfina oral tablets.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 1000 participants with parkinson's disease (including approximately 30 participants with hepatic impairment)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Eisai Inquiry Service eisai-chiken_hotline@hhc.eisai.co.jp

Locations
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Japan
Eisai Trial Site 2 Recruiting
Osaka, Japan
Eisai Trial Site 1 Recruiting
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
More Information
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT04724109    
Other Study ID Numbers: EQF01S
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Parkinson Disease
Parkinsonian Disorders
Prospective
 Non-interventional
Hepatic Impairment
Equfina
Additional relevant MeSH terms:
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Parkinson Disease
Drug-Related Side Effects and Adverse Reactions
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Chemically-Induced Disorders