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Trial record 1 of 1 for:    NCT02477839
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Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT02477839
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Brief Summary:
The purpose of this trial is to assess the efficacy, safety and tolerabilty of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

Condition or disease Intervention/treatment Phase
Epilepsy With Partial-onset Seizures Drug: Lacosamide Other: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

The trial consists of a 7-day Baseline Period, a 20-day Titration Period, a 7-day Maintenance Period, and a 12-day Transition Period for subjects who complete the study and choose to enter the extension study. Subjects who will not enter the extension study will continue after the Maintenance Period with a 16-day Taper Period followed by a 30-day Safety Follow-Up Period. The Taper Period and Safety Follow-Up are also applicable for subjects not eligible for continuation and therefore ending the study earlier.

If subjects meet the eligibility criteria, they will be randomized to receive either lacosamide 8 mg/kg/day to 12 mg/kg/day, or placebo during the Maintenance Phase. The dose of lacosamide will be titrated from 4 mg/kg/day at study start to maximum of 12 mg/kg/day at 4-day intervals of 1-2 mg/kg/day.

All subjects who complete the 20-day Titration Period will enter the 7-day Maintenance Period. No dose adjustment is allowed during the Maintenance Phase. The Treatment Phase is defined as the combined Titration and Maintenance Phases.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Years of Age With Partial-Onset Seizures
Actual Study Start Date : June 5, 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide
Lacosamide syrup 8 mg/kg/day to 12 mg/kg/day
Drug: Lacosamide
Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral
Other Names:
  • Vimpat
  • UCB Code: SPM 927
  • Abreviated name: LCM

Placebo Comparator: Placebo
Matching placebo syrup
Other: Placebo
Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral
Other Name: PBO




Primary Outcome Measures :
  1. Applicable for the US only if dropout rate is <=10%: The change in average daily frequency (ADF) of electrographic partial-onset seizures [ Time Frame: End-of-Baseline Perio to End-of-Maintenance Period ]
    The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG

  2. Applicable for the EU and for the US if dropout rate is >10%: Proportion of responders: >= 50% reduction in partial onset seizure frequency from Baseline to the Maintenance Period [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    The proportion of responders where a responder is a subject experiencing a 50% or greater reduction in their average daily frequency of electrographic partial-onset seizures recorded on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG

  3. Subject withdrawals due to Adverse Events (AEs) during the study [ Time Frame: From the Titration Period (day 1) to the End of Study Visit (up to 93 days) ]
  4. Incidence of Adverse events reported spontaneously by the subject's parent(s) and/or legal representative(s)/caregiver(s) (in accordance with local regulation) or observed by the investigator [ Time Frame: Baseline Period to End-of-Maintenance Period ]

Secondary Outcome Measures :
  1. Absolute change in average daily frequency (ADF) of electrographic partial-onset seizures [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG

  2. Percent change in average daily frequency (ADF) of electrographic partial-onset seizures [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG

  3. Proportion of subjects who achieved "seizure-free" status from all seizure types [ Time Frame: During the End-of-Maintenance Period ]
    Proportion of subjects who achieved "seizure-free" status (yes/no) from all seizure types for subjects who completed at least 48 hours of interpretable video-EEG recording during the End-of-Maintenance Period video-EEG

  4. Proportion of subjects who achieved "seizure-free" status from partial-onset seizure types only [ Time Frame: During the End-of-Maintenance Period ]
    Proportion of subjects who achieved "seizure-free" status (yes/no) from partial-onset seizure types only for subjects who completed at least 48 hours of interpretable video-EEG recording during the End-of-Maintenance Period video-EEG

  5. Proportion of subjects experiencing a >=25% to <50% reduction in average daily frequency (ADF) of electrographic partial-onset seizures [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    Proportion of subjects experiencing a >=25% to <50% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG

  6. Proportion of subjects experiencing a 50% to 75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    Proportion of subjects experiencing 50% to 75% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG

  7. Proportion of subjects experiencing a >75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    Proportion of subjects experiencing a >75% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG

  8. Proportion of subjects experiencing no change in average daily frequency (ADF) of electrographic partial-onset seizures (between <25% reduction and <25% increase) [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    Proportion of subjects experiencing no change in ADF of electrographic partial-onset seizures (between <25% reduction and <25% increase) from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG

  9. Proportion of subjects experiencing an increase in average daily frequency (ADF) of electrographic partial-onset seizures of >=25% [ Time Frame: End-of-Baseline Period to End-of-Maintenance Period ]
    Proportion of subjects experiencing an increase in ADF of electrographic partial-onset seizures of >=25% from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks gestational age]) to <4 years of age
  • Subject has a diagnosis of epilepsy with partial-onset seizures. The results of >=1 prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be consistent with this diagnosis
  • Subject weighs >=4 kg to <30 kg at Visit 1
  • Subject has experienced >=2 partial-onset seizures with or without secondary generalization during each consecutive 7-day period during the 2 weeks prior to Visit 1
  • Subject has >=2 partial-onset seizures with or without secondary generalization during the End-of-Baseline video-EEG. Electrographic seizures are defined as recognizable ictal patterns on an EEG involving >=2 contiguous electrodes. The seizures are initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge lasting a total of >10 seconds
  • Subject is on a stable (concurrently or sequentially) dosage regimen of 1 to 3 AEDs. The dosage regimen of concomitant AED therapy must be kept constant for a period of >=2 weeks prior to Visit 1. A stable daily dosage regimen of a concomitant benzodiazepine (BZD) will be considered as a concomitant AED
  • Vagus nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must have been implanted for >=6 months prior to Visit 1; device settings must be kept stable for >=2 weeks prior to Visit 1 and kept stable during the Baseline, Treatment, and Transition Periods. Use of the VNS device magnet is allowed
  • Subject is an acceptable candidate for venipuncture

Exclusion Criteria:

  • Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to partial-onset seizures is not exclusionary
  • Subject is on a ketogenic diet that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study
  • Subject has creatinine clearance <30 mL/minute
  • Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] >=450 ms)
  • Subject has a hemodynamically significant congenital heart disease
  • Subject has an arrhythmic heart condition requiring medical therapy
  • Subject has a known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias
  • Subject has nonepileptic events that could be confused with seizures. Subjects may be included if epileptic events can be clearly distinguished and the frequency meets the study inclusion criteria
  • Subject has a current diagnosis of Lennox-Gastaut syndrome, epilepsia partialis continua, primary generalized epilepsy, Dravet Syndorme, or seizures that are not of partial-onset origin
  • Subject has a history of generalized convulsive status epilepticus <=2 months prior to Screening (Visit 1)
  • Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for <12 months are excluded. Subjects treated with felbamate for >=12 months prior to Visit 1 and who have not experienced serious toxicity issues are eligible
  • Subject has an acute or subacutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)
  • Subject has a known cardiac sodium channelopathy, such as Brugada syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477839


Contacts
Contact: UCB Cares +1877822 ext 9493

  Show 131 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
Study Director: UCB Cares +1 877 822 9493 (UCB)

Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02477839     History of Changes
Other Study ID Numbers: SP0967
2013-000717-20 ( EudraCT Number )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Epilepsy, children, partial-onset seizures, lacosamide, LCM, pediatric

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants