A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

NCT00903786 | Completed Phase 2 Results

• 1 other identifier: E2007-J081-233
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.

Conditions

Refractory Partial Seizures

Keywords

Seizure; epilepsy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel

  Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 "Classification of Severity of Adverse Drug Reactions of Medicinal Products". TEAEs were defined as AEs that emerged during treatment (absent at pretreatment \[Baseline\]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.

  From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months

Secondary Outcomes (4)

• Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316

  From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months

• Responder Rate During the Treatment Period-LOCF

  Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months

• The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment

  Week 52 and End of Treatment; up to approximately 7 years 2 months

• The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment

  Week 52 and End of Treatment, up to approximately 7 years 2 months

Study Arms (1)

Perampanel

EXPERIMENTAL

Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) \[NCT00849212\]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible). The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest.

Drug: perampanel

Interventions

perampanel DRUG

Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.

Also known as: E2007, Fycompa

Perampanel

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who consent to the study entry on their free will before starting any trial-related activities.
• Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
• Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.

You may not qualify if:

• Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
• Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
• Patients who operate heavy equipment or drive should not be recruited into the study.
• Patients who are ineligible for study entry judged by the investigator or sub-investigator.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (9)

Unknown Facility

Kitakyushu, Fukuoka, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Komatsushimachō, Tokushima, Japan

Location

Unknown Facility

Kodaira, Tokyo, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Eisai Medical Services Inc.
• Organization: Eisai Inc.

esi_medinfo@eisai.com

1-888-422-4743

Study Officials

• Kazunori Saeki

  Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 18, 2009
• Study Start: June 17, 2009
• Primary Completion: August 8, 2016
• Study Completion: October 31, 2016
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2017-09

Locations

JP (9)