Unique ID issued by UMIN | UMIN000044084 |
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Receipt number | R000050324 |
Scientific Title | Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients. |
Date of disclosure of the study information | 2021/04/30 |
Last modified on | 2021/04/30 18:16:05 |
Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Japan |
Epilepsy patients
Neurology | Neurosurgery |
Malignancy
YES
The purpose of this study is to elucidate the individual differences in the clinical effects of perampanel and to design the optimal administration method for epilepsy patients who take perampanel.
PK,PD
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.).
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | Junichi |
Middle name | |
Last name | Kawakami |
Hamamatsu University School of Medicine
Department of Hospital Pharmacy
431-3129
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
053-435-2763
Kawakami-ham@umin.ac.jp
1st name | Rena |
Middle name | |
Last name | Yamaguchi |
Hamamatsu University School of Medicine
Department of Hospital Pharmacy
431-3129
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
053-435-2763
y.rena@hama-med.ac.jp
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Other
Hamamatsu University School of Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
053-435-2763
y.rena@hama-med.ac.jp
NO
2021 | Year | 04 | Month | 30 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 08 | Month | 20 | Day |
2020 | Year | 09 | Month | 03 | Day |
2020 | Year | 09 | Month | 03 | Day |
2025 | Year | 09 | Month | 03 | Day |
Study design: Observational study
Object recruitment: All patients who visit our hospital and meet the selection criteria from September 2020 to August 2025
Primary outcome: Plasma concentrations of perampanel and its free form just before dosing on the 14th day after starting medication or later.
Secondary outcome:
1. Carboxylesterase activity in plasma and its genetic variants
2. Plasma levels of 4beta-hydroxycholesterol and 25-OH vitamin D
3. Polymorphisms of CYP3A4, CYP3A5, P450 oxidoreductase, ABCB1, and OATP1B1
4. Plasma inflammation biomarker and micro-RNA, such as miR-27a, miR-27b, miR-148a, miR-142, miR-30c-1-3p, miR-34a,miR-155, miR-223, miR-128a, miR-627, miR-206
5. Factors related to interindividual variation in plasma concentrations and metabolic ratios of perampanel and its metabolites, its free form.
6. Relationships between pharmacokinetics of perampanel and its metabolites and plasma CYP3A biomarkers
7. Relationships between pharmacokinetics and clinical effects of perampanel, its metabolites and its free form
2021 | Year | 04 | Month | 30 | Day |
2021 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050324
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