Trial Outcomes & Findings for An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects (NCT NCT02427607)

Last Updated: 2018-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months

Results posted on

2018-07-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Perampanel 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.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Perampanel 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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perampanel n=7 Participants 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.
Age, Continuous	35.3 Years STANDARD_DEVIATION 19.20 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months

Population: 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.

Outcome measures

Outcome measures
Measure	Perampanel n=7 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel Non-Serious TEAEs	6 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel Treatment-related TEAEs	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel Severe TEAEs	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel TEAEs leading to study drug dose adjustment	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel Serious TEAE	0 Participants

Adverse Events

Perampanel

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Perampanel n=7 participants at risk 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.
Infections and infestations Nasopharyngitis	42.9% 3/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Infections and infestations Influenza	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Injury, poisoning and procedural complications Fall	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Injury, poisoning and procedural complications Head injury	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Injury, poisoning and procedural complications Humerus fracture	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Metabolism and nutrition disorders Diabetes mellitus	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Metabolism and nutrition disorders Hypercholesterolaemia	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
Metabolism and nutrition disorders Hyperuricaemia	14.3% 1/7 • From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months 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. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.

Additional Information

Hidetaka Hiramatsu

Eisai Co., Ltd.

Phone: +81-3-3817-5245

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER