Clinical trial NCT01151540: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
Official title: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lennox-Gastaut Syndrome
Keywords: Epilepsy
Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-28
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.


Eligibility criteria: Inclusion criteria:

1. Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.
2. Male participants with reproductive ability and female participants with child-bearing potential, or their partners, had to be able to take medically appropriate contraceptive measures.
3. Participants who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the E2080-J081-304 study.
4. Participants who had a family member or a caregiver capable of recording the reporting diary, providing participant information necessary for the study, assisting treatment compliance, and accompanying the participant on scheduled visit days during the study period.

Exclusion criteria:

1. Participants who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the E2080-J081-304 Study.
2. Participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
3. Participants who were judged by the investigator that they were unfit to participate in this clinical trial.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide
timeFrame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months
Secondary outcomes:
measure: Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
timeFrame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
measure: Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days)
timeFrame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
measure: Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures
timeFrame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
measure: Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders)
timeFrame: Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
measure: Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency
timeFrame: Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
Other outcomes:
Locations:
city: Nagoyashi
country: Japan
state: Aichi
city: Matsuyama
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hyogo
city: Yokohama
country: Japan
state: Kanagawa
city: Goshi^shi
country: Japan
state: Kumamoto
city: Iwanuma-shi
country: Japan
state: Miyagi
city: Omura
country: Japan
state: Nagasaki
city: Nara-shi
country: Japan
state: Nara
city: Niigata-shi
country: Japan
state: Niigata
city: Yufu-shi
country: Japan
state: Oita
city: Neyagawa-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Moriyama-shi
country: Japan
state: Shiga
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Kodaira
country: Japan
state: Tokyo
city: Kokubunji-shi
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Toyoma-shi
country: Japan
state: Toyama
city: Okayama
country: Japan
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Hiroki Takano
role: STUDY_DIRECTOR
References: