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

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ClinicalTrials.gov Identifier: NCT00368472
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Perampanel
Enrollment 138

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Perampanel
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 138
Completed 33
Not Completed 105
Reason Not Completed
Adverse Event             22
Medication non-compliance             4
Protocol Violation             2
Request of Investigator or Sponsor             3
Withdrawal by Subject             40
Diary non-compliance             1
Not Specified             32
Missing Final Disposition Date             1
Arm/Group Title Perampanel
Hide Arm/Group Description 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 Number of Baseline Participants 138
Hide Baseline Analysis Population Description
Analysis of baseline characteristics are 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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants
40.7  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants
Female
80
  58.0%
Male
58
  42.0%
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 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.
Time Frame From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Perampanel
Hide Arm/Group Description:
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 Number of Participants Analyzed 138
Measure Type: Number
Unit of Measure: Participants
Treatment-emergent non-serious AEs 112
Treatment-emergent SAEs 33
2.Secondary Outcome
Title 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 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.
Time Frame Baseline up to Week 221
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Perampanel
Hide Arm/Group Description:
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 Number of Participants Analyzed 138
Median (Full Range)
Unit of Measure: Percent Change
-31.5
(-99.2 to 576.1)
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. 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.
Time Frame Baseline up to week 221
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Perampanel
Hide Arm/Group Description:
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 Number of Participants Analyzed 138
Measure Type: Number
Unit of Measure: Percent responders
36.2
Time Frame From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years
Adverse Event Reporting Description 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.
 
Arm/Group Title Perampanel
Hide Arm/Group Description 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.
All-Cause Mortality
Perampanel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Perampanel
Affected / at Risk (%)
Total   33/138 (23.91%) 
Cardiac disorders   
Cardiac arrest  1  1/138 (0.72%) 
Gastrointestinal disorders   
Ileitis  1  1/138 (0.72%) 
General disorders   
Sudden unexplained death in epilepsy  1  1/138 (0.72%) 
Infections and infestations   
Gastroenteritis  1  1/138 (0.72%) 
Intervertebral discitis  1  1/138 (0.72%) 
Pneumonia  1  3/138 (2.17%) 
Wound infection  1  1/138 (0.72%) 
Injury, poisoning and procedural complications   
Fibula fracture  1  1/138 (0.72%) 
Lower limb fracture  1  1/138 (0.72%) 
Overdose  1  1/138 (0.72%) 
Road traffic accident  1  1/138 (0.72%) 
Scapula fracture  1  1/138 (0.72%) 
Therapeutic agent toxicity  1  1/138 (0.72%) 
Tibia fracture  1  1/138 (0.72%) 
Contusion  1  1/138 (0.72%) 
Cervical vertebral fracture  1  1/138 (0.72%) 
Metabolism and nutrition disorders   
Type 2 diabetes mellitus  1  1/138 (0.72%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/138 (0.72%) 
Rotator cuff syndrome  1  1/138 (0.72%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer in situ  1  1/138 (0.72%) 
Breast cancer recurrent  1  1/138 (0.72%) 
Malignant melanoma  1  1/138 (0.72%) 
Prostate cancer  1  1/138 (0.72%) 
Nervous system disorders   
Cerebrovascular accident  1  1/138 (0.72%) 
Convulsion  1  5/138 (3.62%) 
Encephalopathy  1  1/138 (0.72%) 
Epilepsy  1  5/138 (3.62%) 
Grand mal convulsion  1  1/138 (0.72%) 
Guillain-Barre syndrome  1  1/138 (0.72%) 
Paraplegia  1  1/138 (0.72%) 
Postictal state  1  1/138 (0.72%) 
Sciatica  1  1/138 (0.72%) 
Status epilepticus  1  4/138 (2.90%) 
Psychiatric disorders   
Psychotic disorder  1  1/138 (0.72%) 
Schizophrenia  1  1/138 (0.72%) 
Suicide attempt  1  1/138 (0.72%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/138 (0.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Perampanel
Affected / at Risk (%)
Total   112/138 (81.16%) 
Ear and labyrinth disorders   
Vertigo  1  10/138 (7.25%) 
Eye disorders   
Diplopia  1  6/138 (4.35%) 
Gastrointestinal disorders   
Diarrhoea  1  7/138 (5.07%) 
Nausea  1  12/138 (8.70%) 
Vomiting  1  7/138 (5.07%) 
General disorders   
Fatigue  1  17/138 (12.32%) 
Irritability  1  7/138 (5.07%) 
Oedema peripheral  1  7/138 (5.07%) 
Infections and infestations   
Bronchitis  1  6/138 (4.35%) 
Influenza  1  7/138 (5.07%) 
Nasopharyngitis  1  14/138 (10.14%) 
Rhinitis  1  5/138 (3.62%) 
Upper respiratory tract infection  1  12/138 (8.70%) 
Urinary tract infection  1  11/138 (7.97%) 
Viral infection  1  4/138 (2.90%) 
Injury, poisoning and procedural complications   
Contusion  1  12/138 (8.70%) 
Fall  1  12/138 (8.70%) 
Foot fracture  1  4/138 (2.90%) 
Head injury  1  5/138 (3.62%) 
Procedural pain  1  4/138 (2.90%) 
Skin laceration  1  11/138 (7.97%) 
Investigations   
Blood creatine phosphokinase increased  1  5/138 (3.62%) 
Weight decreased  1  2/138 (1.45%) 
Weight increased  1  6/138 (4.35%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/138 (5.07%) 
Back pain  1  15/138 (10.87%) 
Musculoskeletal pain  1  7/138 (5.07%) 
Neck pain  1  7/138 (5.07%) 
Pain in extremity  1  8/138 (5.80%) 
Nervous system disorders   
Ataxia  1  7/138 (5.07%) 
Balance disorder  1  5/138 (3.62%) 
Convulsion  1  13/138 (9.42%) 
Dizziness  1  56/138 (40.58%) 
Headache  1  25/138 (18.12%) 
Paraesthesia  1  4/138 (2.90%) 
Somnolence  1  26/138 (18.84%) 
Tremor  1  7/138 (5.07%) 
Psychiatric disorders   
Anxiety  1  11/138 (7.97%) 
Depression  1  6/138 (4.35%) 
Insomnia  1  7/138 (5.07%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/138 (5.07%) 
Oropharyngeal pain  1  6/138 (4.35%) 
Skin and subcutaneous tissue disorders   
Rash  1  11/138 (7.97%) 
Vascular disorders   
Hypertension  1  6/138 (4.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 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
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
Phone: 1-888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00368472     History of Changes
Other Study ID Numbers: E2007-A001-207
First Submitted: August 22, 2006
First Posted: August 24, 2006
Results First Submitted: June 26, 2015
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015