Trial record 1 of 1 for:
NCT00552305
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00552305
First received: October 30, 2007
Last updated: September 14, 2011
Last verified: September 2011
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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 2 |
| 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 Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- 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) ] [ 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 (up to 8 Years) [ Time Frame: During the Treatment Period (up to 8 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 (up to 8 Years) [ Time Frame: During the Treatment Period (up to 8 years) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
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.
- Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years) [ Time Frame: Treatment Period (up to 8 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. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
| Enrollment: | 370 |
| Study Start Date: | August 2001 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Vimpat
|
Eligibility| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552305
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| United States, Alabama | |
| Birmingham, Alabama, United States | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Los Angeles, California, United States | |
| United States, Colorado | |
| Englewood, Colorado, United States | |
| United States, Florida | |
| Gainesville, Florida, United States | |
| Hollywood, Florida, United States | |
| Miami, Florida, United States | |
| Ponte Verda Beach, Florida, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| Springfield, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| United States, Iowa | |
| Iowa City, Iowa, United States | |
| United States, Kansas | |
| Wichita, Kansas, United States | |
| United States, Kentucky | |
| Crestview Hills, Kentucky, United States | |
| Lexington, Kentucky, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| Frederick, Maryland, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States | |
| Detroit, Michigan, United States | |
| United States, Minnesota | |
| St Paul, Minnesota, United States | |
| United States, Missouri | |
| Chesterfield, Missouri, United States | |
| St Louis, Missouri, United States | |
| United States, New Jersey | |
| Somerset, New Jersey, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| Cleveland, Ohio, United States | |
| Columbus, Ohio, United States | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Irving, Texas, United States | |
| Lubbock, Texas, United States | |
| Wichita Falls, Texas, United States | |
| United States, Vermont | |
| Bennington, Vermont, United States | |
| United States, Virginia | |
| Charlottesville, Virginia, United States | |
| United States, Wisconsin | |
| Marshfield, Wisconsin, United States | |
| Milwaukee, Wisconsin, United States | |
| 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 | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00552305 History of Changes |
| Other Study ID Numbers: | SP615 |
| Study First Received: | October 30, 2007 |
| Results First Received: | February 23, 2011 |
| Last Updated: | September 14, 2011 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013