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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
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: perampanel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1443
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2 mg/day perampanel
Drug: perampanel
2 mg/day, oral administration.
Experimental: 2
4 mg/day perampanel
Drug: perampanel
4 mg/day, oral administration.
Experimental: 3
6 mg/day perampanel
Drug: perampanel
6 mg/day, oral administration.
Experimental: 4
8 mg/day perampanel
Drug: perampanel
8 mg/day, oral administration.
Experimental: 5
10 mg/day perampanel
Drug: perampanel
10 mg/day, oral administration.
Experimental: 6
12 mg/day perampanel
Drug: perampanel
12 mg/day, oral administration.
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Subjects will receive matching placebo tablets.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735397

  Show 244 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Michelle Gee, PhD. Eisai Limited
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00735397     History of Changes
Other Study ID Numbers: E2007-G000-307
Study First Received: August 13, 2008
Last Updated: August 28, 2014
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Partial onset seizures

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014