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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
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
Hide 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
Arm/Group Title Perampanel
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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   --/-- 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Eisai Call Center
Organization: Eisai Inc.
Phone: 888-422-4743
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