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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01393743
First received: July 12, 2011
Last updated: December 7, 2015
Last verified: November 2015
Results First Received: May 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seizure Disorder Generalized Tonic Clonic
Interventions: Drug: perampanel
Drug: Placebo comparator

  Participant Flow
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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
Only the results of the Core Study are presented as the extension study is currently ongoing. 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.
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.

Participant Flow:   Overall Study
    Placebo (Core Study)     Perampanel (Core Study)  
STARTED     82     81 [1]
COMPLETED     72     68  
NOT COMPLETED     10     13  
Adverse Event                 5                 9  
Lost to Follow-up                 1                 1  
Participant's Choice                 2                 3  
Inadequate therapeutic effect                 2                 0  
[1] A total of 82 participants were enrolled but one participant withdrew prior to receiving treatment.



  Baseline Characteristics
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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 Full Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had any postbaseline seizure frequency data during the Randomization Phase.

Reporting Groups
  Description
Placebo (Core Study) Participants received 6 tablets of perampanel matched placebo, once a day.
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  
Number of Participants  
[units: participants]
  81     81     162  
Age  
[units: Years]
Median (Full Range)
  26  
  (14 to 70)  
  26  
  (12 to 58)  
  26  
  (12 to 70)  
Gender  
[units: Participants]
     
Female     45     46     91  
Male     36     35     71  



  Outcome Measures
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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.  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) ]

4.  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) ]

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

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

7.  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   [ 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
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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
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  More Information
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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
Study First Received: July 12, 2011
Results First Received: May 29, 2015
Last Updated: December 7, 2015
Health Authority: United States: Food and Drug Administration