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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000561
• Date of registration: 07-08-2009
• Prospective Registration: Yes
• Primary sponsor: Eisai Inc
• Public title: Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
• Scientific 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.
• Date of first enrolment: 02-09-2009
• Target sample size: 1430
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=762
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia , South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States of America

Contacts

• Name: Rashmi Chitgupi
• Affiliation: PPD Pharmaceutical Development (I) Pvt.Ltd.

• Name: Rashmi Chitgupi
• Affiliation: PPD Pharmaceutical Development (I) Pvt.Ltd.

Key inclusion & exclusion 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 study, 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 nonchildbearing potential (defined as having undergone surgical sterilization, or postmenopausal [more than 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 methods 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 provided in Section 1.3 of Protocol).

5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved AEDs.
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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Refractory partial seizures

Intervention(s)

Intervention1: E2007 (Perampanel): 2 mg, 4 mg, 6 mg, 8 mg,
10 mg, and 12 mg/day, oral administration.
Control Intervention1: Placebo comparator: Subjects will receive matching placebo tablets.

Primary Outcome(s)

Primary efficacy will be assessed by seizure counts (using subjects diaries) documenting the percent change in seizure frequency per 28 days.Timepoint: 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(s)

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.Timepoint: 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

Secondary ID(s)

NCT00735397

2007-006170-28

E2007-G000-307- Amendment F (27 June 2012)

Source(s) of Monetary Support

Eisai Inc., 300 Tice Blvd. Woodcliff Lake, NJ 07677, USA

Secondary Sponsor(s)

PPD Pharmaceutical Development India Pvt Ltd

Ethics review

Status: Approved
Approval date: 17/03/2009
Contact:

Institutional Ethics Committee, Andhra Medical College

Status: Approved
Approval date: 01/05/2009
Contact:

Mallikatta Ethical Committee

Status: Approved
Approval date: 09/05/2009
Contact:

Manavata Clinical Research Institute Ethics Committee

Status: Approved
Approval date: 10/05/2009
Contact:

Institutional Ethical Committee - CARE Foundation

Status: Approved
Approval date: 02/06/2009
Contact:

Central India Medical Research Ethics Committee

Status: Approved
Approval date: 12/06/2009
Contact:

Ethics Committee Poona Hospital Research Centre

Status: Approved
Approval date: 01/08/2009
Contact:

Ethics Committee - SMS Medical College

Status: Approved
Approval date: 13/08/2009
Contact:

Institutional Ethics Committee (Nizams Institute of Medical Sciences)

Status: Approved
Approval date: 24/08/2009
Contact:

Ethics Committee - Jaslok Hospital and Research Centre

Status: Approved
Approval date: 15/09/2009
Contact:

Ethics Committee - KEM Hospital Research Centre

Status: Approved
Approval date: 30/09/2009
Contact:

Ethics Committee Sir Ganga Ram Hospital

Status: Approved
Approval date: 22/10/2009
Contact:

Institutional Ethics Committee, MAMC