4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00368472
• Date of registration: 22/08/2006
• Prospective Registration: Yes
• Primary sponsor: Eisai Inc.
• Public title: 4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
• Scientific title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 (Perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures
• Date of first enrolment: October 2006
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00368472
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Czech Republic, Estonia, Finland, France, Germany, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom, United States

Key inclusion & exclusion criteria

KEY INCLUSION CRITERIA:

1. Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206
(NCT00144690) study or Visit 9 of the E2007-G000-208 (NCT00416195) study.

2. Are reliable and willing to make themselves available for the study period and are
able to record seizures and report adverse events themselves or have a caregiver who
can record and report the events.

3. Females of childbearing potential must continue practicing a medically acceptable
method of contraception (e.g., abstinence, a barrier method plus spermicide, or
Intrauterine device (IUD)) and for 8 weeks after the end of the OLE study. Those women
using hormonal contraceptives must also continue using an additional approved method
of contraception (e.g., a barrier method plus spermicide, or IUD).

4. Are between the ages of 18 and 70 years of age, inclusive.

5. Are at least 40 kg (88 lb) of weight.

6. Are currently being treated with a stable dose of one, or a maximum of three licensed
Anti-epileptic drugs (AEDs) and are known to take their medication(s) as directed.

KEY EXCLUSION CRITERIA:

1. Show evidence of clinically significant disease (cardiac, respiratory,
gastrointestinal, renal disease, etc.,) that, in the opinion of the Investigator(s),
could affect the participant's safety or trial conduct.

2. Show evidence of significant active hepatic disease and/or bilirubin greater than 1.5
mg/dL. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and
aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if
they are less than two times the upper limit of normal (ULN).

3. Show evidence of significant active hematological disease. White blood cell (WBC)
count cannot be less than or equal to 2500/microL or an absolute neutrophil count less
than or equal to 1000/microL.

4. Clinically significant ECG abnormality, including prolonged QTc (defined as greater
than or equal to 450 msec).

5. Presence of major active psychiatric disease. Participants taking a stable dose of
selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Perampanel

Primary Outcome(s)

Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) [Time Frame: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years]

Secondary Outcome(s)

Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline [Time Frame: Baseline up to Week 221]

Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline [Time Frame: Baseline up to week 221]

Secondary ID(s)

E2007-A001-207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00368472