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Trial record 1 of 2 for:    NCT01710657
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A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

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ClinicalTrials.gov Identifier: NCT01710657
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : February 9, 2015
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Tracking Information
First Submitted Date  ICMJE October 17, 2012
First Posted Date  ICMJE October 19, 2012
Results First Submitted Date  ICMJE January 22, 2015
Results First Posted Date  ICMJE February 9, 2015
Last Update Posted Date August 25, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period [ Time Frame: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8) ]
Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Maintenance Period [ Time Frame: From start of the 8-Week Baseline Period (Visit 1 to Visit 3) to the end of the 16-Week Treatment Period (Visit 3 to Visit 8) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate) [ Time Frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) ]
  • Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period [ Time Frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) ]
    Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
  • Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period) [ Time Frame: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8) ]
    Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
  • The portion of individual patients who experience a 50 % or greater reduction in Partial-Onset Seizure frequency from Baseline to the Maintenance Period (50 % responder rate) [ Time Frame: From start of the 8-Week Baseline Period (Visit 1 to Visit 3) to the end of the 12-Week Maintenance Period (Visit 5 to Visit 8) ]
  • Percent change in Partial-Onset Seizure frequency per 28 days from Baseline to the Maintenance Period [ Time Frame: From start of the 8-week Baseline Period (Visit 1 to Visit 3) to the end of the 12-week Maintenance Period (Visit 5 to Visit 8) ]
  • Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Treatment Period (ie, Titration + Maintenance Period) [ Time Frame: From start of the 8-Week Baseline Period (Visit 1 to Visit 3) to the end of the 16-Week Treatment Period (Visit 3 to Visit 8) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization
Brief Summary The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Partial Onset Seizures
Intervention  ICMJE
  • Drug: Lacosamide 50 mg
    • Active Substance: Lacosamide
    • Pharmaceutical Form: Film-coated tablet
    • Concentration: 50 mg
    • Route of Administration: Oral use
    Other Name: Vimpat
  • Drug: Lacosamide 100 mg
    • Active Substance: Lacosamide
    • Pharmaceutical Form: Film-coated tablet
    • Concentration: 100 mg
    • Route of Administration: Oral use
    Other Name: Vimpat
  • Drug: Placebo
    Matching oral Placebo tablets twice daily for 16 weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo for 16 weeks.
    Intervention: Drug: Placebo
  • Experimental: Lacosamide 200 mg/day
    Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
    Interventions:
    • Drug: Lacosamide 50 mg
    • Drug: Lacosamide 100 mg
  • Experimental: Lacosamide 400 mg/day
    Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
    Interventions:
    • Drug: Lacosamide 50 mg
    • Drug: Lacosamide 100 mg
Publications * Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291:56-68. doi: 10.1111/nyas.12213. Review.

*   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: August 19, 2014)
548
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2012)
540
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
  • Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
  • Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
  • Minimum Body Weight of 40 kg

Exclusion Criteria:

  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
  • Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
  • Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
  • Subject has a history of Primary Generalized Seizures
  • Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
  • Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
  • Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
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 China,   Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01710657
Other Study ID Numbers  ICMJE EP0008
2014-003622-41 ( EudraCT Number )
JapicCTI-121988 ( Registry Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UCB Pharma ( UCB Pharma SA )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE UCB Pharma SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE UCB Japan Co. Ltd.
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
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