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Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

NCT00520741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2018-07-19

Study results available
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Summary

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Conditions

Interventions

DRUG

Lacosamide

50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

DRUG

Lacosamide

50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Sponsors & Collaborators

  • UCB BIOSCIENCES, Inc.

    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
2007-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Poland
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00520741 on ClinicalTrials.gov