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

• 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: UCB Pharma SA
• Collaborator: UCB Japan Co. Ltd.
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

Tracking Information

• First Submitted Date: October 17, 2012
• First Posted Date: October 19, 2012
• Results First Submitted Date: January 22, 2015
• Results First Posted Date: February 9, 2015
• Last Update Posted Date: August 25, 2017
• Study Start Date: September 2012
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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) ]

Current Secondary Outcome Measures (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 (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: A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Epilepsy
• Partial Onset Seizures

Intervention

• 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

• 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(1):56-68. doi: 10.1111/nyas.12213.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2014): 548
• Original Estimated Enrollment (submitted: October 17, 2012): 540
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, Japan

Administrative Information

• NCT Number: NCT01710657
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: UCB Pharma ( UCB Pharma SA )
• Original Responsible Party: Same as current
• Current Study Sponsor: UCB Pharma SA
• Original Study Sponsor: Same as current
• Collaborators: UCB Japan Co. Ltd.

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: July 2017