Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

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ClinicalTrials.gov Identifier: NCT00735397

Recruitment Status : Completed

First Posted : August 14, 2008

Results First Posted : January 26, 2016

Last Update Posted : March 14, 2016

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Epilepsy
Intervention	Drug: perampanel
Enrollment	1218

Participant Flow

Recruitment Details	This was an open-label Extension (OLE) study for participants who completed one of the following double-blind (DB), placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305(NCT00699582), and E2007-G000-306 (NCT00700310).
Pre-assignment Details	From a total of 1218 participants who provided informed consent, 2 participants were lost to follow-up and did not have any postbaseline safety data after the first OLE dose.


Arm/Group Title	Perampanel
Arm/Group Description	Participants previously receiving p...
Arm/Group Description	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Period Title: Overall Study
Started	1218
Completed	35
Not Completed	1183
Reason Not Completed
Adverse Event	194
Lost to Follow-up	33
Participant choice	252
Inadequate therapeutic effect	202
Administrative/Other	502

Baseline Characteristics

Arm/Group Title		Perampanel
Arm/Group Description		Participants previously receiving p...
Arm/Group Description		Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Overall Number of Baseline Participants		1218
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	1218 participants
		33 (12 to 76)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1218 participants
	Female	607 49.8%
	Male	611 50.2%

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
Description	An AE was defined as any untoward medical occurrence in a clinical inv...
Description	An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with 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.
Time Frame	From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.


Arm/Group Title	Perampanel
Arm/Group Description:	Participants previously receiving p...
Arm/Group Description:	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Overall Number of Participants Analyzed	1216
Measure Type: Number Unit of Measure: participants
Treatment-emergent non serious AEs	1018
Treatment-emergent SAEs	288

2.Secondary Outcome


Title	Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Description	Seizure frequency was derived from information (seizure count and type...
Description	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 pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.
Time Frame	Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)

Outcome Measure Data

Analysis Population Description

Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.


Arm/Group Title	Overall	Complex Partial Plus Secondarily Generalized Seizures	Secondarily Generalized Seizures
Arm/Group Description:	Participants previously receiving p...	Participants previously receiving p...	Participants previously receiving p...
Arm/Group Description:	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Overall Number of Participants Analyzed	1217	1126	510
Median (Full Range) Unit of Measure: Percent change
Weeks 1-13	-29.14 (-100.0 to 737.1)	-32.42 (-100.0 to 14858.2)	-54.95 (-100.0 to 530.8)
Weeks 14-26, n = 1159, 1073, 482	-38.54 (-100.0 to 866.6)	-43.19 (-100.0 to 12965.9)	-65.69 (-100.0 to 628.6)
Wekks 27-39, n = 1088, 1011, 458	-42.81 (-100.0 to 780.6)	-46.22 (-100.0 to 14092.3)	-77.47 (-100.0 to 756.0)
Weeks 40-52, n = 969, 903, 416	-46.22 (-100.0 to 685.7)	-49.39 (-100.0 to 898.1)	-81.15 (-100.0 to 898.1)
Weeks 53-65, n = 882, 819, 381	-49.34 (-100.0 to 526.4)	-54.95 (-100.0 to 1071.4)	-80.69 (-100.0 to 891.2)
Weeks 66-78, n = 822, 762, 357	-51.65 (-100.0 to 861.5)	-56.25 (-100.0 to 620.9)	-79.98 (-100.0 to 891.2)
Weeks 79-91, n = 762, 703, 329	-53.06 (-100.0 to 697.5)	-55.38 (-100.0 to 1000.6)	-90.68 (-100.0 to 1071.4)
Weeks 92-104, n = 720, 664, 313	-56.59 (-100.0 to 660.9)	-62.11 (-100.0 to 717.2)	-90.33 (-100.0 to 891.2)
Weeks 105-117, n = 676, 624, 295	-59.07 (-100.0 to 627.9)	-63.62 (-100.0 to 627.9)	-84.98 (-100.0 to 1071.4)
Weeks 118-130, n = 642, 590, 279	-60.89 (-100.0 to 540.0)	-66.75 (-100.0 to 821.1)	-100.00 (-100.0 to 1281.0)
Weeks 131-143, n = 583, 535, 258	-60.67 (-100.0 to 716.0)	-65.46 (-100.0 to 717.5)	-99.70 (-100.0 to 801.1)
Weeks 144-156, n = 517, 478, 231	-61.45 (-100.0 to 570.2)	-67.95 (-100.0 to 562.6)	-100.00 (-100.0 to 936.3)
Weeks 157-169, n = 429, 396, 187	-65.46 (-100.0 to 418.3)	-72.21 (-100.0 to 264.4)	-100.00 (-100.0 to 350.0)
Weeks 170-182, n = 323, 297, 137	-64.29 (-100.0 to 367.4)	-76.37 (-100.0 to 268.2)	-100.00 (-100.0 to 269.2)
Weeks 183-195, n = 210, 193, 89	-66.63 (-100.0 to 698.7)	-74.78 (-100.0 to 867.1)	-100.00 (-100.0 to 320.3)
Weeks 196-208, n = 119, 111, 47	-73.30 (-100.0 to 671.8)	-80.77 (-100.0 to 671.8)	-100.00 (-100.0 to 147.3)
Weeks 209-221, n = 59, 57, 22	-72.47 (-100.0 to 226.4)	-80.69 (-100.0 to 211.4)	-100.00 (-100.0 to 55.8)
Weeks 222-234, n = 37, 36, 11	-81.36 (-100.0 to 175.3)	-89.02 (-100.0 to 75.3)	-99.11 (-100.0 to 75.3)
Weeks 235-247, n = 14, 13, 2	-78.10 (-100.0 to 200.4)	-100.0 (-100.0 to 71.4)	-100.00 (-100.0 to -100.0)
Weeks 248-260, n = 5, 5, 1	-97.16 (-100.0 to 250.4)	-98.39 (-100.0 to -90.0)	-98.39 (-98.39 to -98.39)

3.Secondary Outcome


Title	Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Description	Seizure frequency was derived from information (seizure count and type...
Description	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. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.
Time Frame	Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Overall	Complex Partial Plus Secondarily Generalized Seizures	Secondarily Generalized Seizures
Arm/Group Description:	Participants previously receiving p...	Participants previously receiving p...	Participants previously receiving p...
Arm/Group Description:	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Overall Number of Participants Analyzed	1217	1126	510
Measure Type: Number Unit of Measure: Percent responders
Weeks 1-13	30.8	34.8	54.5
Weeks 14-26, n = 1159, 1073, 482	40.9	43.4	58.7
Weeks 27-39, n = 1088, 1011, 458	44.2	47.3	63.3
Weeks 40-52, n = 969, 903, 416	45.6	49.4	67.8
Weeks 53-65, n = 882, 819, 381	49.5	53.2	65.6
Weeks 66-78, n = 822, 762, 357	51.5	54.9	66.1
Weeks 79-91, n = 762, 703, 329	52.9	55.6	66.0
Weeks 92-104, n = 720, 664, 313	57.2	58.6	69.3
Weeks 105-117, n = 676, 624, 295	57.1	59.5	68.1
Weeks 118-130, n = 642, 590, 279	58.9	61.9	71.3
Weeks 131-143, n = 583, 535, 258	59.3	61.5	71.3
Weeks 144-156, n = 517, 478, 231	60.9	62.6	74.0
Weeks 157-169, n = 429, 396, 187	63.2	65.7	76.5
Weeks 170-182, n = 323, 297, 137	60.1	64.3	78.8
Weeks 183-195, n = 210, 193, 89	62.9	68.4	80.9
Weeks 196-208, n = 119, 111, 47	64.7	71.2	85.1
Weeks 209-221, n = 59, 57, 22	67.8	73.7	77.3
Weeks 222-234, n = 37, 36, 11	73.0	75.0	72.7
Weeks 235-247, n = 14, 13, 2	64.3	69.2	100.0
Weeks 248-260, n = 5, 5, 1	80.0	100.0	100.0

Adverse Events

Time Frame	From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
Adverse Event Reporting Description	In this study, treatment emergent AE (defined as an AE/SAE 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.

Arm/Group Title	Perampanel
Arm/Group Description	Participants previously receiving p...
Arm/Group Description	Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
All-Cause Mortality
	Perampanel
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Perampanel
	Affected / at Risk (%)
Total	288/1216 (23.68%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/1216 (0.08%)
Cardiac disorders
Angina pectoris ^† 1	3/1216 (0.25%)
Atrial fibrillation ^† 1	3/1216 (0.25%)
Bradycardia ^† 1	2/1216 (0.16%)
Acute coronary syndrome ^† 1	1/1216 (0.08%)
Angina unstable ^† 1	1/1216 (0.08%)
Atrial flutter ^† 1	1/1216 (0.08%)
Atrioventricular dissociation ^† 1	1/1216 (0.08%)
Cardiac failure ^† 1	1/1216 (0.08%)
Cardiovascular insufficiency ^† 1	1/1216 (0.08%)
Coronary artery stenosis ^† 1	1/1216 (0.08%)
Mitral valve incompetence ^† 1	1/1216 (0.08%)
Myocardial infarction ^† 1	1/1216 (0.08%)
Sick sinas syndrome ^† 1	1/1216 (0.08%)
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy ^† 1	1/1216 (0.08%)
Skull malformation ^† 1	1/1216 (0.08%)
Ear and labyrinth disorders
Vertigo ^† 1	1/1216 (0.08%)
Conductive deafness ^† 1	1/1216 (0.08%)
Endocrine disorders
Goitre ^† 1	1/1216 (0.08%)
Eye disorders
Conjunctivitis allergic ^† 1	1/1216 (0.08%)
Iritis ^† 1	1/1216 (0.08%)
Visual impairment ^† 1	1/1216 (0.08%)
Gastrointestinal disorders
Gastritis ^† 1	3/1216 (0.25%)
Nausea ^† 1	3/1216 (0.25%)
Colitis ^† 1	1/1216 (0.08%)
Colitis ischaemic ^† 1	1/1216 (0.08%)
Colitis microscopic ^† 1	1/1216 (0.08%)
Duodenal ulcer ^† 1	1/1216 (0.08%)
Duodenitis ^† 1	1/1216 (0.08%)
Enterocolitis ^† 1	1/1216 (0.08%)
Gastroesophageal reflux disease ^† 1	1/1216 (0.08%)
Ileus ^† 1	1/1216 (0.08%)
Inguinal hernia ^† 1	1/1216 (0.08%)
Pancreatitis acute ^† 1	1/1216 (0.08%)
Small intestine obstruction ^† 1	1/1216 (0.08%)
Vomiting ^† 1	1/1216 (0.08%)
General disorders
Gait disturbance ^† 1	2/1216 (0.16%)
Pain ^† 1	2/1216 (0.16%)
Cyst ^† 1	1/1216 (0.08%)
Death ^† 1	1/1216 (0.08%)
Drug ineffective ^† 1	1/1216 (0.08%)
Fatigue ^† 1	1/1216 (0.08%)
General physical health deterioration ^† 1	1/1216 (0.08%)
Hyperthermia ^† 1	1/1216 (0.08%)
Non-cardiac chest pain ^† 1	1/1216 (0.08%)
Pyrexia ^† 1	1/1216 (0.08%)
Sudden death ^† 1	1/1216 (0.08%)
Hepatobiliary disorders
Cholelithiasis ^† 1	4/1216 (0.33%)
Cholecystitis ^† 1	2/1216 (0.16%)
Infections and infestations
Pneumonia ^† 1	13/1216 (1.07%)
Urinary tract infection ^† 1	6/1216 (0.49%)
Appendicitis ^† 1	5/1216 (0.41%)
Device related infection ^† 1	2/1216 (0.16%)
Postoperative wound infection ^† 1	2/1216 (0.16%)
Tooth abscess ^† 1	2/1216 (0.16%)
Wound infection staphylococcal ^† 1	2/1216 (0.16%)
Abscess limb ^† 1	1/1216 (0.08%)
Appendicitis perforated ^† 1	1/1216 (0.08%)
Bacterial disease carrier ^† 1	1/1216 (0.08%)
Bronchitis ^† 1	1/1216 (0.08%)
Cellulitis ^† 1	1/1216 (0.08%)
Influenza ^† 1	1/1216 (0.08%)
Klebsiella infection ^† 1	1/1216 (0.08%)
Meningitis ^† 1	1/1216 (0.08%)
Oral infection ^† 1	1/1216 (0.08%)
Pharyngitis ^† 1	1/1216 (0.08%)
Post procedural pneumonia ^† 1	1/1216 (0.08%)
Pyelonephritis ^† 1	1/1216 (0.08%)
Renal cyst infection ^† 1	1/1216 (0.08%)
Respiratory tract infection ^† 1	1/1216 (0.08%)
Sepsis ^† 1	1/1216 (0.08%)
Septic shock ^† 1	1/1216 (0.08%)
Tuberculosis ^† 1	1/1216 (0.08%)
Typhoid fever ^† 1	1/1216 (0.08%)
Wound infection ^† 1	1/1216 (0.08%)
Injury, poisoning and procedural complications
Head injury ^† 1	12/1216 (0.99%)
Ankle fracture ^† 1	7/1216 (0.58%)
Fall ^† 1	5/1216 (0.41%)
Road traffic accident ^† 1	5/1216 (0.41%)
Toxicity to various agents ^† 1	5/1216 (0.41%)
Contusion ^† 1	4/1216 (0.33%)
Facial bones fracture ^† 1	4/1216 (0.33%)
Craniocerebral injury ^† 1	3/1216 (0.25%)
Foot fracture ^† 1	3/1216 (0.25%)
Lumbar vertebral fracture ^† 1	3/1216 (0.25%)
Accidental overdose ^† 1	2/1216 (0.16%)
Brain contusion ^† 1	2/1216 (0.16%)
Clavicle fracture ^† 1	2/1216 (0.16%)
Extradural haematoma ^† 1	2/1216 (0.16%)
Fibula fracture ^† 1	2/1216 (0.16%)
Hand fracture ^† 1	2/1216 (0.16%)
Humerus fracture ^† 1	2/1216 (0.16%)
Jaw fracture ^† 1	2/1216 (0.16%)
Laceration ^† 1	2/1216 (0.16%)
Lower limb fracture ^† 1	2/1216 (0.16%)
Rib fracture ^† 1	2/1216 (0.16%)
Subdural haematoma ^† 1	2/1216 (0.16%)
Tibia fracture ^† 1	2/1216 (0.16%)
Traumatic intracranial haemorrhage ^† 1	2/1216 (0.16%)
Abdominal injury ^† 1	1/1216 (0.08%)
Animal bite ^† 1	1/1216 (0.08%)
Burns second degree ^† 1	1/1216 (0.08%)
Burns third degree ^† 1	1/1216 (0.08%)
Cartilage injury ^† 1	1/1216 (0.08%)
Cervical vertebral fracture ^† 1	1/1216 (0.08%)
Concussion ^† 1	1/1216 (0.08%)
Epidural haemorrhage ^† 1	1/1216 (0.08%)
Excoriation ^† 1	1/1216 (0.08%)
Forearm fracture ^† 1	1/1216 (0.08%)
Gastrointestinal stoma complication ^† 1	1/1216 (0.08%)
Hip fracture ^† 1	1/1216 (0.08%)
Intentional overdose ^† 1	1/1216 (0.08%)
Joint dislocation ^† 1	1/1216 (0.08%)
Limb injury ^† 1	1/1216 (0.08%)
Limb traumatic amputation ^† 1	1/1216 (0.08%)
Muscle strain ^† 1	1/1216 (0.08%)
Neck injury ^† 1	1/1216 (0.08%)
Post concussion syndrome ^† 1	1/1216 (0.08%)
Post procedural haemorrhage ^† 1	1/1216 (0.08%)
Procedural intestinal perforation ^† 1	1/1216 (0.08%)
Radius fracture ^† 1	1/1216 (0.08%)
Skin laceration ^† 1	1/1216 (0.08%)
Skull fracture ^† 1	1/1216 (0.08%)
Skull fractured base ^† 1	1/1216 (0.08%)
Subcutaneous haematoma ^† 1	1/1216 (0.08%)
Subdural haemorrhage ^† 1	1/1216 (0.08%)
Traumatic iritis ^† 1	1/1216 (0.08%)
Wound ^† 1	1/1216 (0.08%)
Investigations
Clostridium test positive ^† 1	1/1216 (0.08%)
Heart rate irregular ^† 1	1/1216 (0.08%)
Weight decreased ^† 1	1/1216 (0.08%)
Metabolism and nutrition disorders
Hyponatraemia ^† 1	3/1216 (0.25%)
Dehydration ^† 1	1/1216 (0.08%)
Diabetic ketoacidosis ^† 1	1/1216 (0.08%)
Hypernatraemia ^† 1	1/1216 (0.08%)
Hypochloraemia ^† 1	1/1216 (0.08%)
Hypovolaemia ^† 1	1/1216 (0.08%)
Musculoskeletal and connective tissue disorders
osteoarthritis ^† 1	5/1216 (0.41%)
Back pain ^† 1	2/1216 (0.16%)
Muscular weakness ^† 1	2/1216 (0.16%)
Bursitis ^† 1	1/1216 (0.08%)
Musculoskeletal chest pain ^† 1	1/1216 (0.08%)
Periarthritis ^† 1	1/1216 (0.08%)
Pseudarthrosis ^† 1	1/1216 (0.08%)
Scoliosis ^† 1	1/1216 (0.08%)
Soft tissue necrosis ^† 1	1/1216 (0.08%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer ^† 1	2/1216 (0.16%)
Benign lung neoplasm ^† 1	1/1216 (0.08%)
Breast cancer ^† 1	1/1216 (0.08%)
Breast cancer metastatic ^† 1	1/1216 (0.08%)
Endometrial adenocarcinoma ^† 1	1/1216 (0.08%)
Glioma ^† 1	1/1216 (0.08%)
Papillary thyroid cancer ^† 1	1/1216 (0.08%)
Tumour pain ^† 1	1/1216 (0.08%)
Uterine leiomyoma ^† 1	1/1216 (0.08%)
Nervous system disorders
Convulsion ^† 1	43/1216 (3.54%)
Status epilepticus ^† 1	16/1216 (1.32%)
Epilepsy ^† 1	15/1216 (1.23%)
Dizziness ^† 1	6/1216 (0.49%)
Grand mal convulsion ^† 1	6/1216 (0.49%)
Seizure cluster ^† 1	6/1216 (0.49%)
Ataxia ^† 1	3/1216 (0.25%)
Partial seizures ^† 1	3/1216 (0.25%)
Partial seizures with secondary generalisation ^† 1	3/1216 (0.25%)
Cerebral haemorrhage ^† 1	2/1216 (0.16%)
Cerebrovascular accident ^† 1	2/1216 (0.16%)
Drug withdrawal convulsions ^† 1	2/1216 (0.16%)
Dysarthria ^† 1	2/1216 (0.16%)
Hemiparesis ^† 1	2/1216 (0.16%)
Hypoasthesia ^† 1	2/1216 (0.16%)
Somnolence ^† 1	2/1216 (0.16%)
Syncope ^† 1	2/1216 (0.16%)
Carotid artery dissection ^† 1	1/1216 (0.08%)
Carpal tunnel syndrome ^† 1	1/1216 (0.08%)
Central nervous system lesion ^† 1	1/1216 (0.08%)
Cerebral infarction ^† 1	1/1216 (0.08%)
Cognitive disorder ^† 1	1/1216 (0.08%)
Coma ^† 1	1/1216 (0.08%)
Complex partial seizures ^† 1	1/1216 (0.08%)
Dementia Alzheimer's type ^† 1	1/1216 (0.08%)
Haemorrhage intracranial ^† 1	1/1216 (0.08%)
Headache ^† 1	1/1216 (0.08%)
Incoherent ^† 1	1/1216 (0.08%)
Memory impairment ^† 1	1/1216 (0.08%)
Multifocal motor nueropathy ^† 1	1/1216 (0.08%)
Peripheral sensorimotor neuropathy ^† 1	1/1216 (0.08%)
Postictal paralysis ^† 1	1/1216 (0.08%)
Psychomotor hyperactivity ^† 1	1/1216 (0.08%)
Simple partial seizures ^† 1	1/1216 (0.08%)
Speech disorder ^† 1	1/1216 (0.08%)
Spinal cord compression ^† 1	1/1216 (0.08%)
Subarachnoid haemorrhage ^† 1	1/1216 (0.08%)
Temporal lobe epilepsy ^† 1	1/1216 (0.08%)
Transient ischaemic attack ^† 1	1/1216 (0.08%)
Tremor ^† 1	1/1216 (0.08%)
Vertebral artery dissection ^† 1	1/1216 (0.08%)
Stupor ^† 1	1/1216 (0.08%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ^† 1	2/1216 (0.16%)
Abortion spontaneous incomplete ^† 1	1/1216 (0.08%)
Psychiatric disorders
Aggression ^† 1	14/1216 (1.15%)
Psychotic disorder ^† 1	8/1216 (0.66%)
Suicidal ideation ^† 1	6/1216 (0.49%)
Affective disorder ^† 1	5/1216 (0.41%)
Depression ^† 1	5/1216 (0.41%)
Acute psychosis ^† 1	4/1216 (0.33%)
Suicide attempt ^† 1	4/1216 (0.33%)
Disorientation ^† 1	3/1216 (0.25%)
Paranoia ^† 1	3/1216 (0.25%)
Abnormal behaviour ^† 1	2/1216 (0.16%)
Agitation ^† 1	2/1216 (0.16%)
Adjustment disorder ^† 1	1/1216 (0.08%)
Anger ^† 1	1/1216 (0.08%)
Catanoia ^† 1	1/1216 (0.08%)
Confusional state ^† 1	1/1216 (0.08%)
Delirium ^† 1	1/1216 (0.08%)
Delusion ^† 1	1/1216 (0.08%)
Delusion of grandeur ^† 1	1/1216 (0.08%)
Epileptic psychosis ^† 1	1/1216 (0.08%)
Hallucination,auditory ^† 1	1/1216 (0.08%)
Homicidal ideation ^† 1	1/1216 (0.08%)
Insomnia ^† 1	1/1216 (0.08%)
Irritability ^† 1	1/1216 (0.08%)
Major depression ^† 1	1/1216 (0.08%)
Mental disorder due to a general medical condition ^† 1	1/1216 (0.08%)
Mental status changes ^† 1	1/1216 (0.08%)
Mood altered ^† 1	1/1216 (0.08%)
Negativism ^† 1	1/1216 (0.08%)
Obsessive thoughts ^† 1	1/1216 (0.08%)
Personlaity change due to a general medical condition ^† 1	1/1216 (0.08%)
Postictal psychosis ^† 1	1/1216 (0.08%)
Renal and urinary disorders
Nephrolithiasis ^† 1	2/1216 (0.16%)
Urinary retention ^† 1	1/1216 (0.08%)
Reproductive system and breast disorders
Dysfuntional uterine bleeding ^† 1	2/1216 (0.16%)
Bartholinitis ^† 1	1/1216 (0.08%)
Breast enlargement ^† 1	1/1216 (0.08%)
Haemorrhagic ovarian cyst ^† 1	1/1216 (0.08%)
Menstrual disorder ^† 1	1/1216 (0.08%)
Ovarian cyst ^† 1	1/1216 (0.08%)
Ovarian mass ^† 1	1/1216 (0.08%)
Ovarian rupture ^† 1	1/1216 (0.08%)
Polycystic ovaries ^† 1	1/1216 (0.08%)
Uterine cyst ^† 1	1/1216 (0.08%)
Uterine haemorrhage ^† 1	1/1216 (0.08%)
Uterine polyp ^† 1	1/1216 (0.08%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	3/1216 (0.25%)
Pneumonia aspiration ^† 1	2/1216 (0.16%)
Acute respiratory failure ^† 1	1/1216 (0.08%)
Chronic obstructive pulmonary disease ^† 1	1/1216 (0.08%)
Nasal septum deviation ^† 1	1/1216 (0.08%)
Pulmonary embolism ^† 1	1/1216 (0.08%)
Respiratory failure ^† 1	1/1216 (0.08%)
Skin and subcutaneous tissue disorders
Dermatitis atopic ^† 1	1/1216 (0.08%)
Rash maculo-papular ^† 1	1/1216 (0.08%)
Surgical and medical procedures
Abortion induced ^† 1	6/1216 (0.49%)
Medical device removal ^† 1	1/1216 (0.08%)
Vascular disorders
Hypertension ^† 1	2/1216 (0.16%)
Aortic aneurysm ^† 1	1/1216 (0.08%)
Deep vein thrombosis ^† 1	1/1216 (0.08%)
Hypotension ^† 1	1/1216 (0.08%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 13.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Perampanel
	Affected / at Risk (%)
Total	1018/1216 (83.72%)
Ear and labyrinth disorders
Vertigo ^† 1	78/1216 (6.41%)
Eye disorders
Diplopia ^† 1	64/1216 (5.26%)
Gastrointestinal disorders
Diarrhoea ^† 1	84/1216 (6.91%)
Nausea ^† 1	115/1216 (9.46%)
Vomiting ^† 1	95/1216 (7.81%)
General disorders
Fatigue ^† 1	182/1216 (14.97%)
Irritability ^† 1	69/1216 (5.67%)
Gait disturbacne ^† 1	80/1216 (6.58%)
Pyrexia ^† 1	79/1216 (6.50%)
Infections and infestations
Influenza ^† 1	70/1216 (5.76%)
Nasopharyngitis ^† 1	142/1216 (11.68%)
Upper respiratory tract infection ^† 1	107/1216 (8.80%)
Injury, poisoning and procedural complications
Fall ^† 1	116/1216 (9.54%)
Laceration ^† 1	67/1216 (5.51%)
Investigations
Weight increased ^† 1	161/1216 (13.24%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	86/1216 (7.07%)
Nervous system disorders
Ataxia ^† 1	84/1216 (6.91%)
Balance disorder ^† 1	74/1216 (6.09%)
Convulsion ^† 1	78/1216 (6.41%)
Dizziness ^† 1	591/1216 (48.60%)
Dysarthria ^† 1	61/1216 (5.02%)
Headache ^† 1	246/1216 (20.23%)
Somnolence ^† 1	266/1216 (21.88%)
Psychiatric disorders
Anxiety ^† 1	79/1216 (6.50%)
Depression ^† 1	82/1216 (6.74%)
Insomnia ^† 1	86/1216 (7.07%)
Irritability ^† 1	125/1216 (10.28%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 13.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Eisai Call Center
Organization:	Eisai Inc.
Phone:	888-422-4743

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Krauss GL, Perucca E, Kwan P, Ben-Menachem E, Wang XF, Shih JJ, Patten A, Yang H, Williams B, Laurenza A. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307. Epilepsia. 2018 Apr;59(4):866-876. doi: 10.1111/epi.14044. Epub 2018 Mar 25.

Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clément JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.

Layout table for additonal information

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00735397
Other Study ID Numbers:	E2007-G000-307
First Submitted:	August 13, 2008
First Posted:	August 14, 2008
Results First Submitted:	September 16, 2015
Results First Posted:	January 26, 2016
Last Update Posted:	March 14, 2016

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