Phase 3 N=54 Treatment

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

Lennox-Gastaut Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01151540 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Mar 2019

Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide — 54; 38; 9; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rufinamide (Drug)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: Eisai Co., Ltd.
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide	54; 38; 9; 2; 3; 12	—
SECONDARY Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)	-39.3; -40.6; -46.8; -47.6; -36.05; -39.25	—
SECONDARY Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days)	-47.7; -48.9; -50.6; -52; -47.35; -46.3	—
SECONDARY Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures	-95; -80.9; -70.5; -85.7; -77.3; -77.3	—
SECONDARY Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders)	6.5; 93.5; 17.4; 82.6; 43.5; 56.5	—
SECONDARY Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency	21.7; 78.3; 23.3; 76.7; 16.7; 83.3	—

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

Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.
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.
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.
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

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.
Participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
Participants who were judged by the investigator that they were unfit to participate in this clinical trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01151540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.