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

Eisai

Status and phase: Completed; Phase 3

Conditions: Lennox-Gastaut Syndrome

Treatments: Drug: Rufinamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151540

E2080-J081-305

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 4 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Rufinamide

Experimental group

Description:

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.

Treatment:

Drug: Rufinamide