Trial record 1 of 1 for:    NCT00552305
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To Determine Tolerability 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:
NCT00552305
First received: October 30, 2007
Last updated: September 14, 2011
Last verified: September 2011

October 30, 2007
September 14, 2011
August 2001
February 2010   (final data collection date for primary outcome measure)
  • 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.
Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ]
Complete list of historical versions of study NCT00552305 on ClinicalTrials.gov Archive Site
  • 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
Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days. [ Time Frame: At periodic clinic visits throughout the trial ]
Not Provided
Not Provided
 
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Partial Epilepsies
Drug: lacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
Other Name: Vimpat
Experimental: Lacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
Intervention: Drug: lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hungary,   Lithuania,   Poland,   Sweden,   Switzerland,   United Kingdom
 
NCT00552305
SP615
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2011

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