A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01964560 |
Recruitment Status :
Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : April 8, 2022
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Sponsor:
UCB BIOSCIENCES, Inc.
Collaborator:
UCB Biopharma SRL
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | October 14, 2013 | ||||||||||||||||
First Posted Date ICMJE | October 17, 2013 | ||||||||||||||||
Last Update Posted Date | April 8, 2022 | ||||||||||||||||
Actual Study Start Date ICMJE | August 2014 | ||||||||||||||||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
Percentage of seizure-free days during the study [ Time Frame: From Week 0 to End of Treatment Period (up to Week 96) ] Percentage of seizure-free days will be measured using data obtained from subject diaries from EP0034 and will be presented for the overall Treatment Period only.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures | ||||||||||||||||
Official Title ICMJE | A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures | ||||||||||||||||
Brief Summary | The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Epilepsy | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Lacosamide
In the first week after enrollment into EP0034 subjects will be dosed according to their weight:
After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets. Interventions:
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Actual Enrollment ICMJE |
540 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
500 | ||||||||||||||||
Estimated Study Completion Date ICMJE | April 2022 | ||||||||||||||||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Month to 17 Years (Child) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czechia, Estonia, France, Georgia, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Montenegro, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Taiwan, Thailand, Ukraine, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | Czech Republic | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT01964560 | ||||||||||||||||
Other Study ID Numbers ICMJE | EP0034 2012-005012-26 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | UCB Pharma ( UCB BIOSCIENCES, Inc. ) | ||||||||||||||||
Study Sponsor ICMJE | UCB BIOSCIENCES, Inc. | ||||||||||||||||
Collaborators ICMJE | UCB Biopharma SRL | ||||||||||||||||
Investigators ICMJE |
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PRS Account | UCB Pharma | ||||||||||||||||
Verification Date | April 2022 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |