A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01710657
First received: October 17, 2012
Last updated: March 4, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Epilepsy
Partial Onset Seizures
Drug: Lacosamide 50 mg
Drug: Lacosamide 100 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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.



Enrollment: 548
Study Start Date: September 2012
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo for 16 weeks.
Drug: Placebo
Matching oral Placebo tablets twice daily for 16 weeks.
Experimental: Lacosamide 200 mg/day
Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
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
Experimental: Lacosamide 400 mg/day
Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
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

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710657

  Show 76 Study Locations
Sponsors and Collaborators
UCB Pharma SA
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01710657     History of Changes
Other Study ID Numbers: EP0008, 2014-003622-41, JapicCTI-121988
Study First Received: October 17, 2012
Results First Received: January 22, 2015
Last Updated: March 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration

Keywords provided by UCB Pharma:
Lacosamide
Epilepsy
Partial Onset Seizures

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 31, 2015