Clinical Trial Results:
A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients with Partial Onset Seizures (Including Secondarily Generalized Seizures)
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Summary
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EudraCT number |
2019-003734-17 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
27 Jul 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Feb 2021
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First version publication date |
07 Feb 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
E2007-J000-342
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03201900 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Eisai Co., Ltd.
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Sponsor organisation address |
4-6-10 Koishikawa, Bunkyo-Ku, Tokyo , Japan, 112-8088
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Public contact |
Inquiry Service., Eisai, Inc., eisai-chiken_hotline@hhc.eisai.co.jp
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Scientific contact |
Inquiry Service., Eisai, Inc., eisai-chiken_hotline@hhc.eisai.co.jp
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jul 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jul 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the seizure-free rate of the 26-week Maintenance Period in untreated subjects with partial onset seizures (POS).
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Protection of trial subjects |
This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use -Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. -Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Jun 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 43
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Country: Number of subjects enrolled |
Korea, Republic of: 46
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Worldwide total number of subjects |
89
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
7
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Adults (18-64 years) |
71
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From 65 to 84 years |
11
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects 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 subjects were screened, of which 07 were screen failures and 91 entered Treatment Phase. Of these, 89 subjects received the study treatment. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
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 subjects who need a higher dose, the 8 mg Treatment Phase [Titration Period {4 weeks} and Maintenance Period {26 weeks}]) and Extension Phase. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Treatment Phase
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Perampanel | ||||||||||||||||||||
Arm description |
Subjects received 2 mg of perampanel tablets orally once daily (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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs). | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Perampanel
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Investigational medicinal product code |
E2007
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Other name |
Fycompa
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects 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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional AEDs.
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Period 2
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Period 2 title |
Extension Phase
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Is this the baseline period? |
No | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Perampanel | ||||||||||||||||||||
Arm description |
Subjects 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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional AEDs. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Perampanel
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Investigational medicinal product code |
E2007
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Other name |
Fycompa
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects 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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional AEDs.
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| Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Eligible subjects who completed Treatment Phase and agreed to continue in the Extension Phase. |
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Baseline characteristics reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Subjects received 2 mg of perampanel tablets orally once daily (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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Subjects received 2 mg of perampanel tablets orally once daily (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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs). | ||
Reporting group title |
Perampanel
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Reporting group description |
Subjects 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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional AEDs. | ||
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End point title |
Percentage of Subjects With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel [1] | ||||||||
End point description |
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 4 mg perampanel. Modified intent to treat (mITT) set: group of subjects 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.
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End point type |
Primary
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End point timeframe |
26 weeks in Maintenance Period of 4 mg perampanel
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive statistics data was planned to be analyzed for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 or 8 mg Perampanel | ||||||||
End point description |
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 subjects 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.
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End point type |
Secondary
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End point timeframe |
26 weeks in Maintenance Period of 4 or 8 mg perampanel
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects 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 | ||||||||
End point description |
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 started 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 phase of 4 mg perampanel. mITT set: group of subjects 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.
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End point type |
Secondary
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End point timeframe |
52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel)
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects 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 | ||||||||
End point description |
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 phase of last evaluated dose of 4 or 8 mg perampanel. mITT set: group of subjects 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.
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End point type |
Secondary
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End point timeframe |
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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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Onset of First Seizure From the First dose of Study Drug in the Maintenance Period of 4 mg Perampanel | ||||||||
End point description |
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 subjects 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. 99999 refers to data not reported as median time was not estimable because less than (<) 50 percent (%) of subjects experienced a POS seizure event.
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End point type |
Secondary
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End point timeframe |
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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| No statistical analyses for this end point | |||||||||
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End point title |
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 | ||||||||
End point description |
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 subjects 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. 99999 refers to data not reported as median time was not estimable because <50 % of subjects experienced a POS seizure event.
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End point type |
Secondary
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End point timeframe |
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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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel | ||||||||
End point description |
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 subjects 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. 99999 refers to median time was not estimable because <50% of subjects discontinued the study.
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End point type |
Secondary
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End point timeframe |
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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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel | ||||||||
End point description |
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 subjects 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. 99999 refers to median time was not estimable because <50% of subjects discontinued the study.
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End point type |
Secondary
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End point timeframe |
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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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug | ||||||||||||
End point description |
The safety analysis set was the group of subjects who signed informed consent, received at least one dose of study drug and had at least one postdose safety assessment.
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End point type |
Secondary
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End point timeframe |
From baseline up to 28 days after last dose of study drug (up to 160 weeks)
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From baseline up to 28 days after last dose of study drug (up to 160 weeks)
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21.0
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Reporting group title |
Perampanel
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Reporting group description |
Subjects 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 subject experienced seizures during 4-mg Maintenance Period, the subject was transitioned to 8-mg Titration Period based on the subject’s safety and tolerability. In 8-mg Titration Period (4 weeks), subjects 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). Subjects 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 until insufficient seizure control or lack of tolerability, or initiation of additional AEDs. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Dec 2017 |
Amendment 02: The purpose of this amendment was to add exclusion of subject who was diagnosed with dementia to clarify that dementia patients were not eligible in this study, concomitant use of antidementia drugs was prohibited and expand prohibited concomitant therapy to neuromodulation therapy (including vagal nerve stimulation and transcranial magnetic stimulation). |
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05 Jul 2018 |
Amendment 04: The purpose of this amendment was to add “Analysis at primary endpoint achievement” to conduct analysis at if the primary endpoint is achieved. |
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22 Feb 2019 |
Amendment 05: The purpose of this amendment was to add the End of Study Visit to clarify how to switch to the commercial product promptly. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
