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

Eisai

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Equfina 50 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT05225324

ME2125-M082-501

Details and patient eligibility

About

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.

Enrollment: 702 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

702 participants in 1 patient group

Equfina 50 mg

Description:

Participants who will be prescribed with Equfina 50 mg tablets, orally within the scope of the approved label for Korea under the medical judgment of the investigator will be observed prospectively for 24 weeks.

Treatment:

Drug: Equfina 50 mg