Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.

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: NCT02710890
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Brief Summary:
EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects >= 1 month to < 17 years of age with epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Lacosamide Phase 2 Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children (>= 1 Month to < 17 Years of Age) With Epilepsy
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide
Up to 2 age-based Cohorts with Cohort 1 including at least 40 subjects who are >=8 to <17 years. For Cohort 2 every attempt will be made to enroll 20 subjects >= 4 to < 8 years of age, 12 subjects >= 2 to < 4 years of age and 12 subjects >= 1 month to < 2 years of age. A Data Monitoring Committee (DMC) will review the safety and tolerability data for each Cohort to make the following recommendations: the progression of the current Cohort, including intravenous (iv) infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2).
Drug: Lacosamide

Pharmaceutical form: solution for infusion

Concentration: 10 mg/ml

Route of Administration: intravenous

Other Name: Vimpat




Primary Outcome Measures :
  1. Number of subjects with at least one adverse event reported spontaneously by the subject/or caregiver (including parent/legal guardian) or observed by the investigator during the study [ Time Frame: From Visit 2 (Day 1) up to the End-of-Study Period (up to Day 37) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  2. Number of subjects that withdraw due to treatment emergent adverse events during the study [ Time Frame: From Visit 2 (Day 1) up to the End-of-Study Period (up to Day 37) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the subjects from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.



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.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female from >=1 month to <17 years of age
  • Subject has a diagnosis of epilepsy with partial-onset seizures or primary generalized tonic-clonic seizures
  • Subject meets 1 of the following criteria:

    1. Open-label lacosmide (OLL) subject: Subject is currently receiving oral lacosmide (LCM) as adjunctive or monotherapy as participants in an open label long-term study (SP848, EP0034, or other pediatric study); OR,
    2. Prescription lacosamide (RxL) subject: Subject is currently receiving prescribed oral LCM from commercial supply (eg, VIMPAT) as adjunctive or monotherapy; OR,
    3. Initiating intravenous lacosamide (IIL) subject: Subject is not currently receiving LCM and will receive intravenous (iv) LCM as adjunctive treatment in EP0060. Initiation of LCM monotherapy is not permitted in IIL subjects.
  • Subject is an OLL or RxL subject and meets both of the following criteria:

    1. Subject has been administered LCM for the treatment of epilepsy for at least 2 weeks prior to Screening; AND
    2. Subject has been administered (OLL) or prescribed (RxL) oral LCM at a dose of 2 mg/kg/day to 12 mg/kg/day (for subjects <50 kg) or 100 mg/day to 600 mg/day (for subjects >=50 kg). Open-label study drug LCM (OLL) or prescribed oral LCM dose (RxL) must be stable for at least 3 days prior to first LCM infusion; OR,
  • Subject is an ILL subject and is on a stable dosage regimen of at least 1 antiepileptic drug (AED). The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 2 weeks prior to Screening.
  • Subject is an acceptable candidate for venipuncture and iv infusion
  • Subject is, in the opinion of the investigator, able to comply with all study requirements. Subject (or parent[s] or legal representative) is willing to comply with all study requirements
  • Subject weighs >=4 kg

Exclusion Criteria:

  • Subject has previously received intravenous (iv) lacosamide (LCM) in this study
  • Subject has any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject's health or compromise the subject's ability to participate in EP0060
  • Subject has clinically significant hypotension or bradycardia in the opinion of the investigator
  • Subject >=6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by positive responses ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening

For open-label lacosamide (OLL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:

- Subject has any ongoing Adverse Event (AE) in their long-term, open-label study that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate EP0060 or the subject meets any of the criteria for required withdrawal from the long-term open-label study

For prescription lacosamide (RxL) and initiating intravenous lacosamide (IIL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:

  • Subject has a medical condition that could reasonably be expected to interfere with drug absorption distribution, metabolism, or excretion
  • Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of participation in EP0060
  • Subject has creatinine clearance less than 30 mL/min
  • Subject has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the principal investigator (ie, second or third degree heart block at rest or a QT prolongation greater than 450 ms)
  • Subject has hemodynamically significant heart disease (eg, heart failure)
  • Subject has an arrhythmic heart condition requiring medical therapy, known cardiac sodium channelopathy, such as Brugada syndrome
  • Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
  • Subject has an acute or subacutely progressive central nervous system disease.
  • Subject has epilepsy secondary to a progressing cerebral disease or any other progressive or neurodegenerative disease (malignant brain tumor or Rasmussen syndrome)
  • Lacosamide is intended for treatment of generalized convulsive status epilepticus
  • Subject has diagnosis of Dravet's syndrome

For IIL subjects, enrollment in EP0060 is not permitted if the following additional criterion is met:

- Subject has been treated with LCM within the last 3 months prior to Screening


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): NCT02710890


Locations
Show Show 23 study locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 8445992273 (UCB)

Layout table for additonal information
Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02710890    
Other Study ID Numbers: EP0060
2014-003294-42 ( EudraCT Number )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Epilepsy
pediatric
intravenous
children
Lacosamide
VIMPAT®
seizure
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action