Clinical trial NCT00903786: A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Official title: A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Partial Seizures
Keywords: Seizure
epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. Patients who consent to the study entry on their free will before starting any trial-related activities.
2. Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
3. 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.

Exclusion criteria:

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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
timeFrame: 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:
measure: Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316
timeFrame: From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months
measure: Responder Rate During the Treatment Period-LOCF
timeFrame: Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months
measure: The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment
timeFrame: Week 52 and End of Treatment; up to approximately 7 years 2 months
measure: The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment
timeFrame: Week 52 and End of Treatment, up to approximately 7 years 2 months
Other outcomes:
Locations:
city: Kitakyusyu
country: Japan
state: Fukuoka
city: Kobe
country: Japan
state: Hyogo
city: Sendai
country: Japan
state: Miyagi
city: Komatsushima
country: Japan
state: Tokushima
city: Kodaira
country: Japan
state: Tokyo
city: Kyoto
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Shizuoka
country: Japan
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Kazunori Saeki
role: STUDY_DIRECTOR
References: