Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

July 28, 2017 updated by: UCB Pharma

An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
    • New South Wales
      • Randwick, New South Wales, Australia
    • Queensland
      • Maroochydore, Queensland, Australia
    • South Australia
      • Woodville, South Australia, Australia
    • Victoria
      • Clayton, Victoria, Australia
      • Parkville, Victoria, Australia
      • West Heidelberg, Victoria, Australia
  • Croatia
      • Zagreb, Croatia
  • Czechia
      • Brno, Czechia
      • Hradec Kralove, Czechia
      • Olomouc, Czechia
      • Ostrava-Trebovice, Czechia
      • Plzen, Czechia
      • Prague, Czechia
  • Finland
      • Helsinki, Finland
      • Kuopio, Finland
      • Oulu, Finland
      • Tampere, Finland
  • France
      • Lille, France
      • Lyon, France
      • Montpellier, France
      • Paris, France
      • Toulouse, France
  • Germany
      • Berlin, Germany
      • Erlangen, Germany
      • Göttingen, Germany
      • Marburg, Germany, 35039
      • München, Germany
      • Ulm, Germany
  • Hungary
      • Budapest, Hungary
      • Pécs, Hungary
      • Szeged, Hungary
      • Szombathely, Hungary
  • Lithuania
      • Kaunas, Lithuania
      • Vilnius, Lithuania
  • Poland
      • Bialystok, Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Warsaw, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • Spain
      • Girona, Spain
      • Granada, Spain
      • Madrid, Spain
      • Zaragoza, Spain
  • Sweden
      • Gothenburg, Sweden
      • Linköping, Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Cardiff, United Kingdom
      • Dundee, United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
      • Salford, United Kingdom
      • Swansea, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of Epilepsy
  • completion of double blind trial

Exclusion Criteria:

  • taking other investigational drug than Lacosamide
  • meeting withdrawal criteria from double blind trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Drug: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Other Names:
  • SPM 927
  • LCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Time Frame: During the Treatment Period (up to 5.5 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
During the Treatment Period (up to 5.5 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Time Frame: During the Treatment Period (up to 5.5 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
During the Treatment Period (up to 5.5 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)
Time Frame: During the Treatment Period (up to 5.5 years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
During the Treatment Period (up to 5.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
Time Frame: Baseline, Treatment Period (up to 5.5 years)

Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Baseline, Treatment Period (up to 5.5 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
Time Frame: Treatment Period (up to 5.5 years)
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Treatment Period (up to 5.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 14, 2007

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0774
  • 2004-000152-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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