To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

June 20, 2018 updated by: UCB Pharma

An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

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

  • Germany
      • Bonn, Germany
      • Erlangen, Germany
      • Kehl Kork, Germany
      • Schwalmstedt-Treysa, Germany
  • Hungary
      • Budapest, Hungary
      • Zalaegerszeg, Hungary
  • Lithuania
      • Kaunas, Lithuania
      • Vilnius, Lithuania
  • Poland
      • Poznan, Poland
  • Sweden
      • Goteborg, Sweden
      • Stockholm, Sweden
  • Switzerland
      • Bern/Biel, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Bucks/London, United Kingdom
      • Glasgow, United Kingdom
      • Liverpool, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Los Angeles, California, United States
    • Colorado
      • Englewood, Colorado, United States
    • Florida
      • Gainesville, Florida, United States
      • Hollywood, Florida, United States
      • Miami, Florida, United States
      • Ponte Vedra Beach, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Frederick, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • Saint Louis, Missouri, United States
    • New Jersey
      • Somerset, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Irving, Texas, United States
      • Lubbock, Texas, United States
      • Wichita Falls, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
    • Wisconsin
      • Marshfield, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

  • Receiving any study drug or experimental device other than lacosamide.
  • Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

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
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
Drug: lacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Time Frame: During the Treatment Period (up to 8 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 8 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Time Frame: During the Treatment Period (up to 8 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 8 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
Time Frame: During the Treatment Period (up to 8 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 8 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 8 Years)
Time Frame: Baseline, End of Treatment Period (up to 8 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, End of Treatment Period (up to 8 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
Time Frame: Treatment Period (up to 8 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 8 years)

Collaborators and Investigators

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

Sponsor

UCB Pharma

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

August 1, 2001

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 1, 2007

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0615

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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