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This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period in untreated participants with partial onset seizures (POS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2007 | Experimental | The Treatment Phase consists of the 4 milligrams (mg) Treatment Phase (the Titration Period [6 weeks] and the Maintenance Period [26 weeks]) and the 8 mg Treatment Phase (the Titration Period [4 weeks] and the Maintenance Period [26 weeks]) if participants require a higher dose. In the 4 mg Titration Period (6 weeks), participants will initiate 2 mg perampanel once daily (QD) for 2 weeks and then will be up-titrated to 4 mg QD and will continue this dose for 4 weeks. If participants have no safety issues at the end of the Titration Period, they will start the 4 mg Maintenance Period for 26 weeks. Participants will only need the higher dose if they are having seizures. In the 8 mg Titration Period (4 weeks), participants will be administered 6 mg perampanel QD for 2 weeks and then will be up-titrated to 8 mg QD and will continue this dose for 2 weeks. If participants have no safety issues at the end of the Titration Period, they will start the 8 mg Maintenance Period for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel. | 26 weeks in Maintenance Period of 4 mg perampanel |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel. |
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Inclusion Criteria:
Exclusion Criteria:
Participants who present only simple partial seizures without motor signs
Participants who have seizure clusters where individual seizures cannot be counted
Participants who present or have a history of Lennox-Gastaut syndrome
Participants who have a history of status epilepticus
Participants who have a history of psychogenic non-epileptic seizures
Participants who have a history of suicidal ideation/attempt
Participants who present clinically problematic psychological or neurological disorder(s)
Evidence of clinically significant disease
Evidence of clinically significant active hepatic disease
A prolonged time from the beginning of the QRS complex to the end of the T wave (QT) interval corrected for heart rate
Participants who have a history of receiving any AEDs (except for AEDs used as rescue treatment), antipsychotics or anti-anxiety drugs within 12 weeks prior to the Pretreatment Phase
Participants who have not used a stable dose of antidepressant in the 12 weeks
Participants who have a history of any type of surgery for brain or central nervous system within 1 year
Participants who have a history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks
Participants who have used intermittent rescue benzodiazepines on 2 or more occasions within 4 weeks
Participants who have a history of receiving any AED polytherapy
Participants who experienced treatment with perampanel
Participants who have had non-constant ketogenic diet within 4 weeks
Participants who have a history of drug or alcohol dependency or abuse
Participants who have had multiple drug allergies or a severe drug reaction to an AED(s)
Females who are breastfeeding or pregnant in the Pretreatment Phase (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test)
Females of childbearing potential who:
Within 28 days before the start of the Pretreatment Phase, did not use a highly effective method of contraception, which includes any of the following:
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation
Participants who have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #18 | Aichi | Japan | ||||
| Eisai Trial Site #19 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34657389 | Derived | Husni RE, Ngo LY, Senokuchi H, Patten A, Hiramatsu H, Watanabe K, Yamamoto T. Experience of perampanel monotherapy beyond initial titration to achieve seizure freedom in patients with focal-onset seizures with newly diagnosed or currently untreated recurrent epilepsy: A post hoc analysis of the open-label Study 342 (FREEDOM). Epilepsia Open. 2022 Mar;7(1):59-66. doi: 10.1002/epi4.12551. Epub 2021 Nov 19. |
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Study consisted of 2 main phases: Treatment Phase (consisted of a 4 milligram [mg] Treatment Phase [Titration Period {6 weeks} and Maintenance Period {26 weeks}], and for those participants who need a higher dose, the 8 mg Treatment Phase [Titration Period {4 weeks} and Maintenance Period {26 weeks}]) and Extension Phase.
Participants took part in the study at 38 investigative sites in Japan and Korea from 28 Jun 2017 to 27 Jul 2020. A total of 98 participants were screened, of which 07 were screen failures and 91 entered Treatment Phase. Of these, 89 participants received the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Perampanel | Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase (Up to 62 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2019 | Jan 10, 2020 |
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| 26 weeks in Maintenance Period of 4 or 8 mg perampanel |
| Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks treatment of 4 mg perampanel. | 52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel) |
| Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 52-week treatment of last evaluated dose of 4 or 8 mg perampanel. | 52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel) |
| Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) |
| Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) |
| Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) |
| Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the date of withdrawal from study, regardless of reason. | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | From baseline up to 28 days after last dose of study drug (up to 160 weeks) |
| Aichi |
| Japan |
| Eisai Trial Site #11 | Fukuoka | Japan |
| Eisai Trial Site #29 | Fukuoka | Japan |
| Eisai Trial Site #4 | Hiroshima | Japan |
| Eisai Trial Site #16 | Hokkaido | Japan |
| Eisai Trial Site #8 | Hokkaido | Japan |
| Eisai Trial Site #14 | Hyōgo | Japan |
| Eisai Trial Site #6 | Hyōgo | Japan |
| Eisai Trial Site #7 | Kagoshima | Japan |
| Eisai Trial Site #9 | Kanagawa | Japan |
| Eisai Trial Site #10 | Kyoto | Japan |
| Eisai Trial Site #30 | Miyagi | Japan |
| Eisai Trial Site #25 | Nagasaki | Japan |
| Eisai Trial Site #27 | Nagasaki | Japan |
| Eisai Trial Site #15 | Nara | Japan |
| Eisai Trial Site #12 | Niigata | Japan |
| Eisai Trial Site #21 | Osaka | Japan |
| Eisai Trial Site #24 | Osaka | Japan |
| Eisai Trial Site #26 | Osaka | Japan |
| Eisai Trial Site #3 | Saitama | Japan |
| Eisai Trial Site #5 | Saitama | Japan |
| Eisai Trial Site #1 | Shizuoka | Japan |
| Eisai Trial Site #22 | Tochigi | Japan |
| Eisai Trial Site #28 | Tokushima | Japan |
| Eisai Trial Site #20 | Tokyo | Japan |
| Eisai Trial Site #23 | Tokyo | Japan |
| Eisai Trial Site #31 | Tokyo | Japan |
| Eisai Trial Site #13 | Yamagata | Japan |
| Eisai Trial Site #17 | Yamaguchi | Japan |
| Eisai Trial Site #32 | Yamaguchi | Japan |
| Eisai Trial Site #38 | Gyeonggi-do | South Korea |
| Eisai Trial Site #36 | Incheon | South Korea |
| Eisai Trial Site # 2 | Seoul | South Korea |
| Eisai Trial Site #33 | Seoul | South Korea |
| Eisai Trial Site #34 | Seoul | South Korea |
| Eisai Trial Site #35 | Seoul | South Korea |
| Eisai Trial Site #37 | Seoul | South Korea |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension Phase (From Week 63 to 156) |
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|
The safety analysis set was the group of participants who signed informed consent, received at least 1 dose of study drug and had at least one post dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Perampanel | Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel. | Modified intent to treat (mITT) set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Number | 95% Confidence Interval | percentage of participants | 26 weeks in Maintenance Period of 4 mg perampanel |
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| Secondary | Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Number | 95% Confidence Interval | percentage of participants | 26 weeks in Maintenance Period of 4 or 8 mg perampanel |
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| Secondary | Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks treatment of 4 mg perampanel. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Number | 95% Confidence Interval | percentage of participants | 52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel) |
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| Secondary | Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel | A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 52-week treatment of last evaluated dose of 4 or 8 mg perampanel. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Number | 95% Confidence Interval | percentage of participants | 52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel) |
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| Secondary | Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Median | 95% Confidence Interval | weeks | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) |
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| Secondary | Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Median | 95% Confidence Interval | weeks | From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) |
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| Secondary | Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Median | 95% Confidence Interval | weeks | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) |
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| Secondary | Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the date of withdrawal from study, regardless of reason. | mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period. | Posted | Median | 95% Confidence Interval | weeks | From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | The safety analysis set was the group of participants who signed informed consent, received at least one dose of study drug and had at least one postdose safety assessment. | Posted | Count of Participants | Participants | From baseline up to 28 days after last dose of study drug (up to 160 weeks) |
|
From baseline up to 28 days after last dose of study drug (up to 160 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Perampanel | Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs. | 0 | 89 | 13 | 89 | 73 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Otitis media chronic | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Postictal state | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Auditory disorder | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Angular cheilitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Trichophytosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Postictal headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thyroid function test abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Urethritis gonococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Posterior capsule opacification | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival atrophy | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Inquiry Service. | Eisai, Inc. | none | eisai-chiken_hotline@hhc.eisai.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2019 | Jan 10, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal of consent |
|
| Other |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|