NCT03780907

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

A Randomised, Double-Blind, Placebo-Controlled Study of the Tolerability, Safety and Pharmacokinetics of E2007 in Epileptic Patients With Partial and Generalised Seizures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-02-14
• Primary completion: 2003-08-06
• Completion: 2003-08-06
• First posted: 2018-12-19
• Last updated: 2018-12-19

Locations

1 site across 1 country: Germany