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Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy

NCT03780907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-12-19

No results posted yet for this study

Summary

The objectives of this study were to assess the tolerability and safety of E2007 in patients with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007 in epileptic patients receiving at least one concomitant anti-epileptic drug.

Conditions

Interventions

DRUG

E2007

1 mg of E2007 was administered by mouth once daily.

DRUG

E2007

2 mg of E2007 was administered by mouth once daily.

DRUG

Placebo

Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-14
Primary Completion
2003-08-06
Completion
2003-08-06

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

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 NCT03780907 on ClinicalTrials.gov