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

NCT01151540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-03-11

Study results available
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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

Interventions

DRUG

Rufinamide

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

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hiroki Takano · Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01151540 on ClinicalTrials.gov