Epilepsy patients
Conditions
Interventions
None listed
Sponsors
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Persons over 20 years old who have been taking perampanel for at least 21 days 2) Those who the doctor has determined to be able to participate in this study 3) Those who have obtained consent to participate in this study by signing a consent form by the person or his / her substitute. 4) Persons who have consented to the use of the sample or information in research by means of a written consent
Exclusion criteria
Exclusion criteria: 1) Patients with severe hepatic/renal dysfunction 2) Patients who did not obtain written consent 3) Patients with significantly poor medication compliance 4) patients who are judged to be inappropriate by the doctor in charge 5) Patients who did not consent to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The total blood concentration and free form blood concentration(including optical isomers) of Perampanel and its metabolites. 2. Free form fraction of Perampanel and its metabolites. 3. Blood kinetics Parameter fluctuation factors(clinical laboratory values, glycoalbumin, diseases, concomitant medications, inflammatory markers, liver, and kidney function marker). Study1: Relationship between blood levels and side effects (psychiatric symptoms, somnolence, weight gain). Study2: Relationship between blood concentration and liver function marker(4-beta hydroxylated cholesterol in the blood, 25 hydroxylated vitamin D in blood, 25 hydroxylated vitamin D3 in blood, miRNA-24b), Genetic polymorphism of drug-metabolizing enzyme(CYP3A4, CYP3A5), etc.). | — |
Countries
Japan
Contacts
Public ContactRena Yamaguchi
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Outcome results
None listed