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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00735397
First received: August 13, 2008
Last updated: August 28, 2014
Last verified: August 2014

August 13, 2008
August 28, 2014
October 2008
November 2014   (final data collection date for primary outcome measure)
Primary efficacy will be assessed by seizure counts (using subject's diaries) documenting the percent change in seizure frequency per 28 days. [ Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between. ] [ Designated as safety issue: No ]
Efficacy will be assessed by seizure counts (subject's diaries). [ Time Frame: Assessments are done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between. Subjects maintain seizure diary cards throughout entire study. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00735397 on ClinicalTrials.gov Archive Site
Secondary efficacy measures will evaluate the delayed treatment effect by summarizing previous endpoints over the open-label treatment phase relative to the pre-randomization phase of the double-blind study. [ Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts. After 16 weeks, they will be done every 12 wks w/interim telephone contacts in between. ] [ Designated as safety issue: No ]
Safety and tolerability will be examined based on the nature, frequency, and severity of adverse events, vital signs, 12-lead ECG abnormalities, chemistry and hematology laboratory test results. [ Time Frame: Assessments are done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between. Subjects maintain seizure diary cards throughout entire study. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

The purpose of this study is to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Epilepsy
  • Drug: perampanel
    2 mg/day, oral administration.
  • Drug: perampanel
    4 mg/day, oral administration.
  • Drug: perampanel
    6 mg/day, oral administration.
  • Drug: perampanel
    8 mg/day, oral administration.
  • Drug: perampanel
    10 mg/day, oral administration.
  • Drug: perampanel
    12 mg/day, oral administration.
  • Drug: Placebo
    Subjects will receive matching placebo tablets.
  • Experimental: 1
    2 mg/day perampanel
    Intervention: Drug: perampanel
  • Experimental: 2
    4 mg/day perampanel
    Intervention: Drug: perampanel
  • Experimental: 3
    6 mg/day perampanel
    Intervention: Drug: perampanel
  • Experimental: 4
    8 mg/day perampanel
    Intervention: Drug: perampanel
  • Experimental: 5
    10 mg/day perampanel
    Intervention: Drug: perampanel
  • Experimental: 6
    12 mg/day perampanel
    Intervention: Drug: perampanel
  • Placebo Comparator: Placebo
    Matching Placebo
    Intervention: Drug: Placebo
Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clément JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: Results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1443
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Each subject must meet all of the following criteria to be enrolled in this study:

  1. Have completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
  2. Provide written informed consent signed by subject or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained).
  3. Be considered reliable and willing to be available for the study period and able to record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
  4. Females should be either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must agree to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (as described previously) throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data).
  5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.

Exclusion Criteria:

Subjects who meet the following criteria will be excluded from the study:

1. Those who, for any reason, discontinued early from the preceding double-blind study.

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   China,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Ukraine,   United Kingdom
 
NCT00735397
E2007-G000-307
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Michelle Gee, PhD. Eisai Limited
Eisai Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP