Trial record 1 of 1 for:    NCT00522275
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Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00522275
First received: August 27, 2007
Last updated: September 19, 2014
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Partial Epilepsies
Drug: lacosamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • 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) ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • 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) ] [ Designated as safety issue: No ]
    Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.


Secondary Outcome Measures:
  • Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) [ Time Frame: Baseline, Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
    Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

  • Percentage of at Least 50% Responders During the Treatment Period (Maximum 6 Years) [ Time Frame: Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
    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.


Enrollment: 308
Study Start Date: October 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522275

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Los Angeles, California, United States
San Francisco, California, United States
United States, Colorado
Englewood, Colorado, United States
United States, Connecticut
Fairfield, Connecticut, United States
United States, Florida
Bradenton, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Springfield, Illinois, United States
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Indianapolis, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
Bethesda, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Golden Valley, Minnesota, United States
St. Cloud, Minnesota, United States
St. Paul, Minnesota, United States
United States, Missouri
Chesterfield, Missouri, United States
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Somerset, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
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
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
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
United States, South Carolina
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
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Dallas, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, West Virginia
Morgantown, West Virginia, United States
United States, Wisconsin
Marshfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00522275     History of Changes
Other Study ID Numbers: SP0756
Study First Received: August 27, 2007
Results First Received: October 28, 2010
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Adjunctive treatment in epilepsy
add-on treatment for epilepsy
partial seizures
AEDs
antiepileptic drugs
seizures

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014