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

June 20, 2018 updated by: UCB BIOSCIENCES, Inc.

An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 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)

308

Phase

  • Phase 3

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Los Angeles, California, United States
      • San Francisco, California, United States
    • Colorado
      • Englewood, Colorado, United States
    • Connecticut
      • Fairfield, Connecticut, United States
    • Florida
      • Bradenton, Florida, United States
      • Jacksonville, Florida, United States
      • Maitland, Florida, United States
      • Saint Petersburg, Florida, United States
      • Tallahassee, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Golden Valley, Minnesota, United States
      • Saint Cloud, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • New Jersey
      • Somerset, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Buffalo, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Durham, North Carolina, United States
      • Greenville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Beaufort, South Carolina, United States
      • Charleston, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Morgantown, West 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

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
Drug: lacosamide
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

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 (Maximum 6 Years)
Time Frame: During the Treatment Period (Maximum 6 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 (Maximum 6 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Time Frame: During the Treatment Period (Maximum 6 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 (Maximum 6 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Time Frame: During the Treatment Period (Maximum 6 years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
During the Treatment Period (Maximum 6 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Time Frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
Time Frame: Treatment Period (Maximum 6 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.
Treatment Period (Maximum 6 years)

Collaborators and Investigators

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

Sponsor

UCB BIOSCIENCES, Inc.

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

October 1, 2004

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (ESTIMATE)

August 29, 2007

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0756
  • 2014-004398-18 (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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