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Trial record 1 of 1 for:    NCT00515619
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Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

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ClinicalTrials.gov Identifier: NCT00515619
Recruitment Status : Completed
First Posted : August 14, 2007
Results First Posted : September 9, 2011
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE August 13, 2007
First Posted Date  ICMJE August 14, 2007
Results First Submitted Date  ICMJE August 5, 2011
Results First Posted Date  ICMJE September 9, 2011
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE December 2004
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Official Title  ICMJE An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures
Brief Summary The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Intervention: Drug: Lacosamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2008)
376
Original Actual Enrollment  ICMJE
 (submitted: August 13, 2007)
232
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Croatia,   Czechia,   Finland,   France,   Germany,   Hungary,   Lithuania,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00515619
Other Study ID Numbers  ICMJE SP0774
2004-000152-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
PRS Account UCB Pharma
Verification Date July 2017

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