Trial record 1 of 1 for:    E2007 G000 232
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Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01527006
First received: November 10, 2011
Last updated: June 13, 2016
Last verified: June 2016
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Central Nervous System
Intervention: Drug: perampanel

  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
Of the 63 participants who were enrolled, 13 participants were screen failures and 50 participants were eligible to continue in the Core Study. Of the 42 subjects who completed the Core Study, 41 subjects continued into the Extension Phase.

Reporting Groups
  Description
Cohort ( ≥ 2 to < 7 Years of Age) During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
Cohort ( ≥ 7 to < 12 Years of Age) During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.

Participant Flow for 2 periods

Period 1:   Core Study
    Cohort ( ≥ 2 to < 7 Years of Age)     Cohort ( ≥ 7 to < 12 Years of Age)  
STARTED     22     28  
COMPLETED     20     22  
NOT COMPLETED     2     6  
Adverse Event                 0                 2  
Lost to Follow-up                 0                 1  
Subject Choice                 1                 0  
Inadequate Therapeutic Effect                 1                 0  
Withdrawal by Subject                 0                 1  
Not Specified                 0                 2  

Period 2:   Extension Phase
    Cohort ( ≥ 2 to < 7 Years of Age)     Cohort ( ≥ 7 to < 12 Years of Age)  
STARTED     19 [1]   22  
COMPLETED     13     14  
NOT COMPLETED     6     8  
Adverse Event                 4                 2  
Lost to Follow-up                 0                 1  
Subject Choice                 1                 1  
Inadequate therapeutic effect                 1                 1  
Not Specified                 0                 3  
[1] Of the 20 subjects who completed the Core Study, 19 subjects continued into the Extension Phase.



  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.
No text entered.

Reporting Groups
  Description
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
Total Total of all reporting groups

Baseline Measures
    Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study     Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study     Total  
Number of Participants  
[units: participants]
  22     28     50  
Age  
[units: Years]
Median (Full Range)
  5  
  (2 to 6)  
  9  
  (7 to 11)  
  7.5  
  (2 to 11)  
Gender  
[units: Participants]
     
Female     7     9     16  
Male     15     19     34  



  Outcome Measures
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1.  Primary:   Apparent Clearance (CL/F) of Perampanel [Core Study]   [ Time Frame: From Day 8 up to Day 78 ]

2.  Primary:   Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]   [ Time Frame: From Day 8 up to Day 78 ]

3.  Secondary:   Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]   [ Time Frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15 ]

4.  Secondary:   50% Responder Rate During the Maintenance Period-LOCF [Core Study]   [ Time Frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11 ]

5.  Secondary:   Seizure-free Rate During the Maintenance Period [Core Study]   [ Time Frame: Week 9 to Week 11 ]

6.  Secondary:   The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]   [ Time Frame: Week 0 (Baseline), Week 11 or EOT ]

7.  Secondary:   Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel   [ Time Frame: For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase ]

8.  Secondary:   Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]   [ Time Frame: Week 5 or at the time of early discontinuation ]

9.  Secondary:   Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]   [ Time Frame: Week 5 or at the time of early discontinuation ]

10.  Secondary:   Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]   [ Time Frame: Week 5 or at the time of early discontinuation ]

11.  Secondary:   Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]   [ Time Frame: Week 5 or at the time of early discontinuation ]

12.  Secondary:   Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]   [ Time Frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 ]

13.  Secondary:   50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]   [ Time Frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 ]

14.  Secondary:   Seizure-free Rate During the Overall Treatment Duration [Extension Phase]   [ Time Frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 ]

15.  Secondary:   The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]   [ Time Frame: Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT ]

16.  Other Pre-specified:   The Effect of Demographics on Population PK Parameters: AUC   [ Time Frame: 11 weeks ]

17.  Other Pre-specified:   The Effect of Demographics on Population PK Parameters: Cmax   [ Time Frame: 11 weeks ]

18.  Other Pre-specified:   The Effect of Demographics on Population PK Parameters: Tmax   [ Time Frame: 11 weeks ]

19.  Other Pre-specified:   The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC   [ Time Frame: 11 weeks ]

20.  Other Pre-specified:   The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax   [ Time Frame: 11 weeks ]

21.  Other Pre-specified:   The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax   [ Time Frame: 11 weeks ]


  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



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01527006     History of Changes
Other Study ID Numbers: E2007-G000-232
Study First Received: November 10, 2011
Results First Received: July 31, 2015
Last Updated: June 13, 2016
Health Authority: United States: Food and Drug Administration