A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)

Parkinson Disease Clinical Trial

Official title:

Equfina Tablet 50 mg Post Marketing Surveillance Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225324
• Other study ID #: ME2125-M082-501
• Status: Recruiting
• Start date: June 3, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Eisai Inc.
• Contact: Jina Jieun Kim
• Phone: +82-10-9708-0744
• Email: j16-kim[@]eisaikorea.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the following in relation to the safety of Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants with idiopathic Parkinson's disease experiencing end of dose motor fluctuations who are receiving Equfina Tablet 50 mg as adjunctive treatment to levodopa-containing products

2. Participants who have given their consent to study participation about the use of personal data and medical data

Exclusion Criteria:

1. Participants taking over monoamine oxidase (MAO) inhibitors (example, selegiline hydrochloric acid [HCl], rasagiline mesylate)

2. Participants taking opioid drugs (example, pethidine HCl containing drugs, tramadol HCl containing products or tapentadol HCl)

3. Participants taking serotonergic drugs (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitor, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, noradrenergic and serotonergic antidepressant) or psychostimulant drugs (example, methylphenidate HCl, lisdexamfetamine dimesylate)

4. Participants taking dextromethorphan

5. Participants with severe hepatic impairment (Child-Pugh C)

6. Participants with a history of hypersensitivity to any of the ingredients of Equfina Tablet 50 mg

7. Pregnant women or women who may be pregnant

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Equfina 50 mg
Equfina 50 mg tablets.

Locations

Country	Name	City	State
Korea, Republic of	Site #05	Busan
Korea, Republic of	Site #06	Cheonan	Gyeongsangnam-do
Korea, Republic of	Site #03	Cheongju	Chungcheongbuk-do
Korea, Republic of	Site #16	Daegu
Korea, Republic of	Site #25	Daegu
Korea, Republic of	Site #20	Daejeon
Korea, Republic of	Site #19	Gwanju
Korea, Republic of	Site #08	Iksan	Jeollabuk-do
Korea, Republic of	Site #11	Ilsan	Gyeonggi-do
Korea, Republic of	Site #24	Incheon
Korea, Republic of	Site #02	Jeju
Korea, Republic of	Site #17	Jeonju-si	Jeollabuk-do
Korea, Republic of	Site #18	Jeonju-si	Jeollabuk-do
Korea, Republic of	Site #26	Jeonju-si	Jeollabuk-do
Korea, Republic of	Site #09	Jinju	Gyeongsangnam-do
Korea, Republic of	Site #21	Sejong
Korea, Republic of	Site #01	Seoul
Korea, Republic of	Site #04	Seoul
Korea, Republic of	Site #10	Seoul
Korea, Republic of	Site #12	Seoul
Korea, Republic of	Site #13	Seoul
Korea, Republic of	Site #14	Seoul
Korea, Republic of	Site #15	Seoul
Korea, Republic of	Site #27	Ulsan
Korea, Republic of	Site #23	Wonju-si	Gangwon-do
Korea, Republic of	Site #07	Yangsan-si	Gyeongsangnam-do
Korea, Republic of	Site #22	Yongin-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With SAEs	A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.	From first dose of study drug up to 24 weeks
Primary	Number of Participants With ADRs	An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.	From first dose of study drug up to 24 weeks
Primary	Number of Participants With Unexpected AEs	An AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, which do not necessarily have a causal relationship with the drug in question. An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug.	From first dose of study drug up to 24 weeks
Primary	Number of Participants With Unexpected ADRs	An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug.	From first dose of study drug up to 24 weeks
Primary	Number of Participants With Known ADRs	An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. Known ADRs are those listed in product licensure/notification of the drug.	From first dose of study drug up to 24 weeks
Primary	Number of Participants With Non-serious ADRs	An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.	From first dose of study drug up to 24 weeks
Secondary	Change From Baseline in Score of Clinical Global Impression of Change (CGIC)	The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.	Baseline up to 24 weeks