Determine Safety 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:
NCT00522275
First received: August 27, 2007
Last updated: February 8, 2013
Last verified: August 2011

August 27, 2007
February 8, 2013
October 2004
October 2009   (final data collection date for primary outcome measure)
  • Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment period (maximum 6 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 (Maximum 6 Years) [ Time Frame: During the Treatment period (maximum 6 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 (Maximum 6 Years) [ Time Frame: During the Treatment Period (maximum 6 years) ] [ Designated as safety issue: No ]
    Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
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 NCT00522275 on ClinicalTrials.gov Archive Site
  • Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) [ Time Frame: Baseline, Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
    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 (Maximum 6 Years) [ Time Frame: Treatment period (maximum 6 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.
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, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ]
Not Provided
Not Provided
 
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 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 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Partial Epilepsies
Drug: lacosamide
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Experimental: Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
Intervention: Drug: lacosamide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
October 2009
October 2009   (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
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00522275
SP756
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
August 2011

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