Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
NCT ID: NCT00522275
Last Updated: 2018-07-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
308 participants
INTERVENTIONAL
2004-10-31
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
NCT00552305
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
NCT00655486
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
NCT00515619
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT01118962
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
NCT00520741
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
lacosamide
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lacosamide
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
16 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
San Francisco, California, United States
Englewood, Colorado, United States
Fairfield, Connecticut, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Golden Valley, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Paul, Minnesota, United States
Chesterfield, Missouri, United States
Somerset, New Jersey, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Marshfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.
Related Links
Access external resources that provide additional context or updates about the study.
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-004398-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0756
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.