We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393743
First Posted: July 13, 2011
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
Results First Submitted: May 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seizure Disorder Generalized Tonic Clonic
Interventions: Drug: Perampanel
Drug: Placebo comparator

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 307 participants who were screened, 143 participants were screen failures and 164 participants were eligible to continue in the study but 1 participant withdrew prior to receiving treatment.

Reporting Groups
  Description
Placebo (Core Study) Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
Perampanel (Core Study) Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
Perampanel (Extension Phase) The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.

Participant Flow for 2 periods

Period 1:   Core Study
    Placebo (Core Study)   Perampanel (Core Study)   Perampanel (Extension Phase)
STARTED   82 [1]   81 [1]   0 
COMPLETED   72   68   0 
NOT COMPLETED   10   13   0 
Adverse Event                5                9                0 
Lost to Follow-up                1                1                0 
Participant's Choice                2                3                0 
Inadequate therapeutic effect                2                0                0 
[1] Treated

Period 2:   Extension Phase
    Placebo (Core Study)   Perampanel (Core Study)   Perampanel (Extension Phase)
STARTED   0   0   138 [1] 
COMPLETED   0   0   78 
NOT COMPLETED   0   0   60 
Adverse Event                0                0                12 
Lost to Follow-up                0                0                2 
Participant choice                0                0                16 
Inadequate therapeutic effect                0                0                7 
Withdrawal by Subject                0                0                8 
Pregnancy                0                0                1 
Not specified                0                0                14 
[1] Continuation into the Extension Phase was optional.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Core Study Full Analysis Set (FAS) and Extension Phase FAS included participants who were randomized to study drug, received at least 1 dose of study drug in that phase, had baseline and any postbaseline seizure frequency data during the Randomization Phase, and at least 1 observation of valid seizure diary data during treatment duration.

Reporting Groups
  Description
Placebo (Core Study) Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
Perampanel (Core Study) Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
Total Total of all reporting groups

Baseline Measures
   Placebo (Core Study)   Perampanel (Core Study)   Total 
Overall Participants Analyzed 
[Units: Participants]
 82   81   163 
Age 
[Units: Years]
Median (Full Range)
 26 
 (14 to 70) 
 26 
 (12 to 58) 
 26 
 (12 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      46  56.1%      46  56.8%      92  56.4% 
Male      36  43.9%      35  43.2%      71  43.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)   [ Time Frame: Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks) ]

2.  Primary:   50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study)   [ Time Frame: Baseline (4 or 8 weeks) and Maintenance (13 weeks) ]

3.  Primary:   50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase – (for Extension Phase)   [ Time Frame: Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase ]

4.  Secondary:   Median Percent Change in All Seizure Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)   [ Time Frame: Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks) ]

5.  Secondary:   Median Percent Change in Primary Generalized Seizure Subtype Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)   [ Time Frame: Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks) ]

6.  Secondary:   50% Responder Rate for All Seizures During Maintenance-LOCF - (for Core Study)   [ Time Frame: Baseline (4 or 8 weeks) and Maintenance (13 weeks) ]

7.  Secondary:   50% Responder Rate for Primary Generalized Seizure Subtype During Maintenance Period - LOCF - (for Core Study)   [ Time Frame: Baseline (4 or 8 weeks) and Maintenance (13 weeks) ]

8.  Secondary:   Percent Change From Core Study Prerandomization Phase in Primary Generalized Tonic-Clonic (PGTC) Seizure Frequency Per 28 Days - (for Extension Phase)   [ Time Frame: Date of first dose of study drug to date of last dose of study drug in the Extension Phase ]

9.  Secondary:   Summary of Percent Change From Pre-Perampanel Baseline in Seizure Frequency Per 28 Days - (for Extension Phase)   [ Time Frame: Weeks: 1 to 13, 14 to 26, 27 to 39, 40 to 52, 53 to 65, 66 to 78, 79 to 91, 92 to 104, 105 to 117, 118 to 130, 131 to 143, greater than or equal to 144 ]

10.  Secondary:   Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of Perampanel in Subjects With Inadequately Controlled PGTC Seizures - (for Core Study)   [ Time Frame: For each participant, from the first treatment dose till 30 days after the last dose or up to 21 weeks for core study and 142 weeks for extension phase. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
phone: 1-888-422-4743
e-mail: esi_medinfo@eisai.com


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

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01393743     History of Changes
Other Study ID Numbers: E2007-G000-332
First Submitted: July 12, 2011
First Posted: July 13, 2011
Results First Submitted: May 29, 2015
Results First Posted: January 11, 2016
Last Update Posted: August 28, 2017