UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Acronym	Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Scientific Title	Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Scientific Title:Acronym	Elucidation of individual differences in pharmacokinetics and clinical effects of perampanel in epilepsy patients.
Region	Japan

Condition
Condition	Epilepsy patients
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	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.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.).
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Kawakami
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital Pharmacy
Zip code	431-3129
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2763
Email	Kawakami-ham@umin.ac.jp

Public contact
Name of contact person	1st name Rena Middle name Last name Yamaguchi
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital Pharmacy
Zip code	431-3129
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2763
Homepage URL
Email	y.rena@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine Department of Hospital Pharmacy
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine Department of Hospital Pharmacy
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel	053-435-2763
Email	y.rena@hama-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 20 Day
Date of IRB	2020 Year 09 Month 03 Day
Anticipated trial start date	2020 Year 09 Month 03 Day
Last follow-up date	2025 Year 09 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

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

Management information
Registered date	2021 Year 04 Month 30 Day
Last modified on	2021 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050324