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A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

NCT01710657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2017-08-25

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

Conditions

Interventions

DRUG

Lacosamide 50 mg

* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use

DRUG

Lacosamide 100 mg

* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use

DRUG

Placebo

Matching oral Placebo tablets twice daily for 16 weeks.

Sponsors & Collaborators

  • UCB Japan Co. Ltd.

    collaborator INDUSTRY

  • UCB Pharma SA

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • China
  • Japan

Study Locations

More Related Trials

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 NCT01710657 on ClinicalTrials.gov