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Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515619
First Posted: August 14, 2007
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
August 13, 2007
August 14, 2007
August 5, 2011
September 9, 2011
August 28, 2017
December 2004
August 2010   (Final data collection date for primary outcome measure)
  • Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ]
    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 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ]
    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 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 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.
Not Provided
Complete list of historical versions of study NCT00515619 on ClinicalTrials.gov Archive Site
  • Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years) [ Time Frame: Baseline, Treatment Period (up to 5.5 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.

  • Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years) [ Time Frame: Treatment Period (up to 5.5 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
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Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
Drug: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Other Names:
  • SPM 927
  • LCM
Experimental: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Intervention: Drug: Lacosamide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
376
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of Epilepsy
  • completion of double blind trial

Exclusion Criteria:

  • taking other investigational drug than Lacosamide
  • meeting withdrawal criteria from double blind trial
Sexes Eligible for Study: All
16 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Croatia,   Czechia,   Finland,   France,   Germany,   Hungary,   Lithuania,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
Czech Republic
 
NCT00515619
SP0774
2004-000152-16 ( EudraCT Number )
No
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
UCB Pharma
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP