Trial Outcomes & Findings for 4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures (NCT NCT00368472)

Last Updated: 2015-12-10

Results Overview

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years

Results posted on

2015-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Perampanel Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Overall Study STARTED	138
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	105

Reasons for withdrawal

Reasons for withdrawal
Measure	Perampanel Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Overall Study Adverse Event	22
Overall Study Medication non-compliance	4
Overall Study Protocol Violation	2
Overall Study Request of Investigator or Sponsor	3
Overall Study Withdrawal by Subject	40
Overall Study Diary non-compliance	1
Overall Study Other	32
Overall Study Missing Final Disposition Date	1

Baseline Characteristics

4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perampanel n=138 Participants Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Age, Continuous	40.7 Years STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years

Population: Safety Analysis Set was defined as participants who received at least 1 dose of open-label perampanel and had at least 1 safety assessment after the first dose of perampanel in the OLE study.

Outcome measures

Outcome measures
Measure	Perampanel n=138 Participants Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) Treatment-emergent non-serious AEs	112 Participants
Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) Treatment-emergent SAEs	33 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 221

Population: The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.

Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.

Outcome measures

Outcome measures
Measure	Perampanel n=138 Participants Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline	-31.5 Percent Change Interval -99.2 to 576.1

SECONDARY outcome

Timeframe: Baseline up to week 221

Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.

Outcome measures

Outcome measures
Measure	Perampanel n=138 Participants Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline	36.2 Percent responders

Adverse Events

Perampanel

Serious events: 33 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Perampanel n=138 participants at risk Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Injury, poisoning and procedural complications Fibula fracture	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Lower limb fracture	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Overdose	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Road traffic accident	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Scapula fracture	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Tibia fracture	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders Cardiac arrest	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Cerebrovascular accident	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Convulsion	3.6% 5/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Encephalopathy	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Epilepsy	3.6% 5/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Grand mal convulsion	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Guillain-Barre syndrome	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Paraplegia	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Postictal state	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Sciatica	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Status epilepticus	2.9% 4/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders Sudden unexplained death in epilepsy	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders Psychotic disorder	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders Schizophrenia	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders Suicide attempt	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders Ileitis	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Gastroenteritis	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Intervertebral discitis	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Pneumonia	2.2% 3/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Wound infection	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Contusion	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.72% 1/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Other adverse events

Other adverse events
Measure	Perampanel n=138 participants at risk Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
Vascular disorders Hypertension	4.3% 6/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders Fatigue	12.3% 17/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders Irritability	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders Oedema peripheral	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders Anxiety	8.0% 11/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders Depression	4.3% 6/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders Insomnia	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Contusion	8.7% 12/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Fall	8.7% 12/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Foot fracture	2.9% 4/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Head injury	3.6% 5/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Procedural pain	2.9% 4/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications Skin laceration	8.0% 11/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations Blood creatine phosphokinase increased	3.6% 5/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations Weight decreased	1.4% 2/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations Weight increased	4.3% 6/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.3% 6/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Ataxia	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Balance disorder	3.6% 5/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Convulsion	9.4% 13/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Dizziness	40.6% 56/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Headache	18.1% 25/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Paraesthesia	2.9% 4/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Somnolence	18.8% 26/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders Tremor	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Eye disorders Diplopia	4.3% 6/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Ear and labyrinth disorders Vertigo	7.2% 10/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders Diarrhoea	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders Nausea	8.7% 12/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders Vomiting	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Skin and subcutaneous tissue disorders Rash	8.0% 11/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Back pain	10.9% 15/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Neck pain	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders Pain in extremity	5.8% 8/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Bronchitis	4.3% 6/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Influenza	5.1% 7/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Nasopharyngitis	10.1% 14/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Rhinitis	3.6% 5/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Upper respiratory tract infection	8.7% 12/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Urinary tract infection	8.0% 11/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations Viral infection	2.9% 4/138 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Additional Information

Eisai Medical Services

Eisai, Inc.

Phone: 1-888-422-4743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER