Clinical trial NCT03754582: A Study of Intravenous Perampanel in Japanese Participants With Epilepsy
Official title: A Multicenter, Uncontrolled, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Perampanel as Substitute for Oral Tablet in Subjects With Partial Onset Seizures (Including Secondarily Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Seizures
Keywords: Partial Onset Seizures
Secondarily Generalized Seizures
Primary Generalized Tonic-Clonic Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day \[mg/day\]) as an adjunctive therapy in participants with epilepsy with partial onset seizures (POS) (including secondarily generalized seizures) or primary generalized tonic-clonic (PGTC) seizures.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of epilepsy with POS (including secondarily generalized seizures) or PGTC seizures according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981).
2. Receiving a stable dose regimen of oral perampanel.
3. Receiving a concomitant stable dose regimen of marketed AEDs. No change of dosing regimen for concomitant AEDs is planned during the intravenous Treatment and Follow-up Phases.
4. Considered reliable and willing to be available for the study period by the investigator, and are able to record seizures and report AEs by themselves or have a caregiver who can record seizures and report AEs for them.

Exclusion Criteria:

1. A history of drug or alcohol dependency or abuse.
2. A history of status epilepticus.
3. Unsuitable for venipuncture and intravenous administration.
4. Requires medical intervention due to safety issues related to concomitant administration of AEDs.
5. A history of suicidal ideation/attempt.
6. Clinical symptoms or imaging suggest progressive central nervous system (CNS) abnormality, disorder, or brain tumor.
7. Current evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the participant's safety, interfere with the study assessments or need prohibited medications as specified in the study protocol.
8. Clinically significant abnormal laboratory values.
9. Females of childbearing potential who:

   * In the Pretreatment Phase, are breastfeeding or pregnant (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] test).
   * Within 28 days before Visit 1, did not use a highly effective method of contraception, which includes any of the following:

     * total abstinence (if it is their preferred and usual lifestyle).
     * an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
     * a contraceptive implant.
     * an oral contraceptive (with additional barrier method). (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before Day 1 of the Treatment Phase and throughout the entire study period, and for 28 days after the last dose of study drug).
     * have a vasectomized partner with confirmed azoospermia.
     * Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after the last dose of study drug.
10. Participation in a study involving administration of an investigational drug or device within 28 days before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
11. A prolonged QT interval corrected using Fridericia's formula (QTcF) interval (greater than \[\>\] 450 millisecond \[ms\]) as demonstrated by a repeated ECG.
12. A vagus nerve stimulation (VNS) implanted.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
measure: Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
timeFrame: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)
measure: Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase
timeFrame: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
measure: Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase
timeFrame: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
measure: Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase
timeFrame: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)
Secondary outcomes:
measure: Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase
timeFrame: Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose)
measure: Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
timeFrame: Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusions
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Eisai trial site 5
state: Fukuoka
city: Sapporo
country: Japan
facility: Eisai trial site 12
state: Hokkaido
city: Omura
country: Japan
facility: Eisai trial site 9
state: Nagasaki
city: Osakasayama
country: Japan
facility: Eisai trial site 7
state: Osaka
city: Asaka
country: Japan
facility: Eisai trial site 2
state: Saitama
city: Hamamatsu
country: Japan
facility: Eisai trial site 13
state: Shizuoka
city: Kodaira
country: Japan
facility: Eisai trial site 8
state: Tokyo
city: Hiroshima
country: Japan
facility: Eisai trial site 10
city: Kagoshima
country: Japan
facility: Eisai trial site 6
city: Niigata
country: Japan
facility: Eisai trial site 1
city: Okayama
country: Japan
facility: Eisai trial site 11
city: Shizuoka
country: Japan
facility: Eisai trial site 3
city: Yamagata
country: Japan
facility: Eisai trial site 4
Study officials:
References: