Parkinson Disease
Conditions
Keywords
Equfina
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.
Interventions
DRUGEqufina 50 mg
Equfina 50 mg tablets.
Sponsors
Eisai Korea Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unexpected AEs | From first dose of study drug up to 24 weeks | 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. |
| Number of Participants With SAEs | From first dose of study drug up to 24 weeks | 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. |
| Number of Participants With ADRs | From first dose of study drug up to 24 weeks | 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. |
| Number of Participants With Non-serious ADRs | From first dose of study drug up to 24 weeks | 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. |
| Number of Participants With Unexpected ADRs | From first dose of study drug up to 24 weeks | 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. |
| Number of Participants With Known ADRs | From first dose of study drug up to 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Score of Clinical Global Impression of Change (CGIC) | Baseline up to 24 weeks | 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. |
Countries
South Korea
Outcome results
None listed