A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome

Phase 1

Conditions: ennox-Gastaut Syndrome
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2016-004953-34-Outside-EU/EEA

Lead Sponsor: Eisai Co, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 54

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety of long term administration of E2080 in the participants with Lennox-Gastaut syndrome (LSG) who completed the E2080-J081-304 study.;Secondary Objective: To evaluated the long term efficacy of rufinamide under the open-label treatment in participants with LGS who completed the E2080-J081-304 study.;Primary end point(s): Number of participants with treatment emergent adverse events and serious adverse events;Timepoint(s) of evaluation of this end point: approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Percent change in tonic-atonic seizure frequency per 28 days relative to Baseline Phase<br><br>2. Percentage change in total seizure frequency per 28 days by visit relative to the Baseline Phase<br><br>3. Percentage change in the frequency of seizures other than tonic-atonic seizures, per 28 days by visit relative to the Baseline Phase<br><br>4. 25%, 50%, 75%, 100% responder and aggravated subjects in tonic-atonic seizure frequency per 28 days by visit relative to the Baseline Phase;Timepoint(s) of evaluation of this end point: Baseline, Week 12, Week 24, Week 32, Week 40, Week 52, and Week 52 last observation carried forward (LOCF)