Clinical trial NCT05225324: A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)
Official title: Equfina Tablet 50 mg Post Marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Equfina
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants administered with Equfina Tablet 50 mg tablet will be enrolled in this study.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With SAEs
timeFrame: From first dose of study drug up to 24 weeks
measure: Number of Participants With ADRs
timeFrame: From first dose of study drug up to 24 weeks
measure: Number of Participants With Unexpected AEs
timeFrame: From first dose of study drug up to 24 weeks
measure: Number of Participants With Unexpected ADRs
timeFrame: From first dose of study drug up to 24 weeks
measure: Number of Participants With Known ADRs
timeFrame: From first dose of study drug up to 24 weeks
measure: Number of Participants With Non-serious ADRs
timeFrame: From first dose of study drug up to 24 weeks
Secondary outcomes:
measure: Change From Baseline in Score of Clinical Global Impression of Change (CGIC)
timeFrame: Baseline up to 24 weeks
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Site #03
state: Chungcheongbuk-do
city: Wonju-si
country: Korea, Republic of
facility: Site #23
state: Gangwon-do
city: Ilsan
country: Korea, Republic of
facility: Site #11
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Site #22
state: Gyeonggi-do
city: Cheonan
country: Korea, Republic of
facility: Site #06
state: Gyeongsangnam-do
city: Jinju
country: Korea, Republic of
facility: Site #09
state: Gyeongsangnam-do
city: Yangsan-si
country: Korea, Republic of
facility: Site #07
state: Gyeongsangnam-do
city: Iksan
country: Korea, Republic of
facility: Site #08
state: Jeollabuk-do
city: Jeonju-si
country: Korea, Republic of
facility: Site #17
state: Jeollabuk-do
city: Jeonju-si
country: Korea, Republic of
facility: Site #18
state: Jeollabuk-do
city: Jeonju-si
country: Korea, Republic of
facility: Site #26
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Site #05
city: Daegu
country: Korea, Republic of
facility: Site #16
city: Daegu
country: Korea, Republic of
facility: Site #25
city: Daejeon
country: Korea, Republic of
facility: Site #20
city: Gwanju
country: Korea, Republic of
facility: Site #19
city: Incheon
country: Korea, Republic of
facility: Site #24
city: Jeju
country: Korea, Republic of
facility: Site #02
city: Sejong
country: Korea, Republic of
facility: Site #21
city: Seoul
country: Korea, Republic of
facility: Site #01
city: Seoul
country: Korea, Republic of
facility: Site #04
city: Seoul
country: Korea, Republic of
facility: Site #10
city: Seoul
country: Korea, Republic of
facility: Site #12
city: Seoul
country: Korea, Republic of
facility: Site #13
city: Seoul
country: Korea, Republic of
facility: Site #14
city: Seoul
country: Korea, Republic of
facility: Site #15
city: Ulsan
country: Korea, Republic of
facility: Site #27
Study officials:
References: