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

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ClinicalTrials.gov Identifier: NCT00700310
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : November 22, 2012
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Refractory Partial Seizures
Interventions Drug: perampanel
Drug: Placebo
Enrollment 712
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Hide Arm/Group Description Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks) Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
Period Title: Overall Study
Started 187 180 174 171
Completed 166 154 158 145
Not Completed 21 26 16 26
Reason Not Completed
Adverse Event             6             10             5             11
Lost to Follow-up             4             1             0             1
Withdrawal by Subject             8             9             8             8
Lack of Efficacy             0             3             0             1
Administrative/Other             1             3             1             3
Randomized, Not Treated             2             0             2             2
Arm/Group Title Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg Total
Hide Arm/Group Description Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks) Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks) Total of all reporting groups
Overall Number of Baseline Participants 185 180 172 169 706
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants 180 participants 172 participants 169 participants 706 participants
<18 Years 14 21 13 12 60
18-64 Years 169 156 158 153 636
>64 Years 2 3 1 4 10
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 180 participants 172 participants 169 participants 706 participants
Female
90
  48.6%
95
  52.8%
84
  48.8%
92
  54.4%
361
  51.1%
Male
95
  51.4%
85
  47.2%
88
  51.2%
77
  45.6%
345
  48.9%
[1]
Measure Description: The number of participants started is not consistant with the number of Baseline Participants due to 6 participants who were randomized in the study, but not treated with study drug.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants 180 participants 172 participants 169 participants 706 participants
White 119 119 105 116 459
Asian 34 35 37 28 134
Chinese 31 25 29 25 110
Other 1 1 1 0 3
[1]
Measure Description: Race
1.Primary Outcome
Title Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
Hide Description Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Time Frame Baseline (Pre-randomization) through Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.
Arm/Group Title Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Hide Arm/Group Description:
Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
Overall Number of Participants Analyzed 184 180 172 169
Median (Full Range)
Unit of Measure: Percent Change
-10.69
(-100.0 to 420.6)
-13.63
(-100.0 to 346.3)
-23.33
(-100.0 to 416.0)
-30.80
(-100.0 to 390.6)
2.Secondary Outcome
Title Responder Rate
Hide Description The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.
Time Frame Baseline (Pre-randomization) through Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full ITT Analysis Set.
Arm/Group Title Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Hide Arm/Group Description:
Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
Overall Number of Participants Analyzed 184 180 172 169
Measure Type: Number
Unit of Measure: Percentage of Participants
Responders (Yes) 17.9 20.6 28.5 34.9
Non-Responders (No) 82.1 79.4 71.5 65.1
3.Secondary Outcome
Title Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
Hide Description Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Time Frame Baseline (Pre-randomization) through Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full ITT Analysis Set
Arm/Group Title Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Hide Arm/Group Description:
Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
Overall Number of Participants Analyzed 169 167 157 154
Median (Full Range)
Unit of Measure: Percent Change
-17.63
(-100.0 to 602.9)
-20.50
(-100.0 to 13744.2)
-31.18
(-100.0 to 416.0)
-38.69
(-100.0 to 583.3)
Time Frame From the time the subject signed the informed consent form to 30 days after the last dose of the study drug.
Adverse Event Reporting Description Adverse events were assessed at clinical visits based on the subject's diary, vitals, weight, physical examination, neurological exam, and laboratory evaluations; and by telephone interviews/contact.
 
Arm/Group Title Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Hide Arm/Group Description Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks) Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
All-Cause Mortality
Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/185 (4.86%)   6/180 (3.33%)   6/172 (3.49%)   6/169 (3.55%) 
Endocrine disorders         
Goitre  0/185 (0.00%)  1/180 (0.56%)  0/172 (0.00%)  0/169 (0.00%) 
Eye disorders         
Conjunctivitis allergic  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Iritis  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Infections and infestations         
Appendicitis  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Wound infection  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Bronchitis  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  0/169 (0.00%) 
Orchitis  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  0/169 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  0/185 (0.00%)  1/180 (0.56%)  0/172 (0.00%)  0/169 (0.00%) 
Contusion  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Head injury  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Post concussion syndrome  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Rib fracture  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Road traffic accident  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Traumatic brain injury  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  0/169 (0.00%) 
Metabolism and nutrition disorders         
Diabetes mellitus  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  0/169 (0.00%) 
Musculoskeletal and connective tissue disorders         
Bone erosion  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Soft tissue necrosis  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign lung neoplasm  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Nervous system disorders         
Convulsion  3/185 (1.62%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Dizziness  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Epilepsy  1/185 (0.54%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Simple partial seizures  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Somnolence  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Tremor  0/185 (0.00%)  0/180 (0.00%)  1/172 (0.58%)  0/169 (0.00%) 
Grand mal convulsion  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  0/169 (0.00%) 
Transient ischaemic attack  1/185 (0.54%)  0/180 (0.00%)  0/172 (0.00%)  0/169 (0.00%) 
Psychiatric disorders         
Aggression  0/185 (0.00%)  1/180 (0.56%)  0/172 (0.00%)  0/169 (0.00%) 
Confusional state  0/185 (0.00%)  1/180 (0.56%)  0/172 (0.00%)  0/169 (0.00%) 
Delirium  0/185 (0.00%)  1/180 (0.56%)  0/172 (0.00%)  0/169 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  0/185 (0.00%)  1/180 (0.56%)  0/172 (0.00%)  0/169 (0.00%) 
Skin and subcutaneous tissue disorders         
Ecchymosis  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Surgical and medical procedures         
Medical device removal  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
Vascular disorders         
Aortic stenosis  0/185 (0.00%)  0/180 (0.00%)  0/172 (0.00%)  1/169 (0.59%) 
1
Term from vocabulary, MedDRA V. 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Perampanel 2mg Perampanel 4mg Perampanel 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/185 (25.95%)   61/180 (33.89%)   66/172 (38.37%)   79/169 (46.75%) 
General disorders         
Fatigue  5/185 (2.70%)  8/180 (4.44%)  13/172 (7.56%)  9/169 (5.33%) 
Gait disturbance  2/185 (1.08%)  1/180 (0.56%)  2/172 (1.16%)  9/169 (5.33%) 
Infections and infestations         
Nasopharyngitis  3/185 (1.62%)  7/180 (3.89%)  9/172 (5.23%)  3/169 (1.78%) 
Upper respiratory tract infection  5/185 (2.70%)  11/180 (6.11%)  6/172 (3.49%)  3/169 (1.78%) 
Nervous system disorders         
Dizziness  18/185 (9.73%)  18/180 (10.00%)  28/172 (16.28%)  45/169 (26.63%) 
Headache  16/185 (8.65%)  16/180 (8.89%)  19/172 (11.05%)  18/169 (10.65%) 
Somnolence  12/185 (6.49%)  22/180 (12.22%)  15/172 (8.72%)  27/169 (15.98%) 
1
Term from vocabulary, MedDRA V. 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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 Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00700310     History of Changes
Other Study ID Numbers: E2007-G000-306
2007-006169-33 ( EudraCT Number )
First Submitted: June 17, 2008
First Posted: June 18, 2008
Results First Submitted: October 23, 2012
Results First Posted: November 22, 2012
Last Update Posted: January 21, 2016