Clinical Trial Results:
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Summary
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EudraCT number |
2016-004945-10 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
21 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Feb 2018
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First version publication date |
21 Feb 2018
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Other versions |
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-J000-341
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02427607 | ||
WHO universal trial number (UTN) |
- | ||
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,
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Public contact |
Customer Joy Department. EJ, Eisai Co., ltd, 81-3 3817-5245, esi_medinfo@eisai.com
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Scientific contact |
Customer Joy Department. EJ, Eisai Co., ltd, 81-3 3817-5245, esi_medinfo@eisai.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000467-PIP01-08 | ||
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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Nov 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Sep 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Sep 2016
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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 safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.
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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 GCP 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 |
12 May 2015
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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: 7
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Worldwide total number of subjects |
7
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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) |
1
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Adults (18-64 years) |
5
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
This study was conducted at 8 centers in Japan during the period of 12 May 2015 to 21 Sep 2016. E2007-J000-341 is an open-label extension of E2007-G000-332. | ||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Perampanel | ||||||||||
Arm description |
Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Perampanel
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Investigational medicinal product code |
E2007
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
A minimum perampanel dose of 2 mg per day was administered orally with the maximum daily dose of perampanel permitted was 12 mg per day. Doses of perampanel were allowed to be adjusted based on clinical judgment.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. |
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End point title |
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel [1] | ||||||||||||||||||
End point description |
Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening.
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End point type |
Primary
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End point timeframe |
From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
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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: Statistic analysis not performed |
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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 first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
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Adverse event reporting additional description |
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||
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 |