A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

NCT ID: NCT01151540

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Lennox-Gastaut Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rufinamide

Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.

Group Type: EXPERIMENTAL

Rufinamide

Intervention Type: DRUG

The target dosage is approximately 45 mg/kg/day, taken orally twice a day.

Interventions

Rufinamide

The target dosage is approximately 45 mg/kg/day, taken orally twice a day.

Intervention Type: DRUG

Other Intervention Names

E2080, BANZEL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroki Takano

Role: STUDY_DIRECTOR

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

Locations

Nagoya, Aichi-ken, Japan

Matsuyama, Ehime, Japan

Fukuoka, Fukuoka, Japan

Hiroshima, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Yokohama, Kanagawa, Japan

Goshi^shi, Kumamoto, Japan

Iwanuma-shi, Miyagi, Japan

Ōmura, Nagasaki, Japan

Nara, Nara, Japan

Niigata, Niigata, Japan

Yufu-shi, Oita Prefecture, Japan

Neyagawa, Osaka, Japan

Osaka, Osaka, Japan

Suita-shi, Osaka, Japan

Moriyama-shi, Shiga, Japan

Shizuoka, Shizuoka, Japan

Kodaira, Tokyo, Japan

Kokubunji-shi, Tokyo, Japan

Shinjuku, Tokyo, Japan

Toyoma-shi, Toyama, Japan

Okayama, , Japan

Countries

Japan

Other Identifiers

E2080-J081-305

Identifier Type: -

Identifier Source: org_study_id