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History of Changes for Study: NCT02710890
Study to Investigate Safety and Tolerability of Intravenous Lacosamide as Replacement of Oral Lacosamide in Children.
Latest version (submitted November 26, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 14, 2016 None (earliest Version on record)
2 January 12, 2017 Study Status, Outcome Measures, Study Identification, Contacts/Locations, Eligibility, Arms and Interventions, Study Description, Oversight and Sponsor/Collaborators
3 March 2, 2017 Study Status and Oversight
4 April 10, 2017 Study Status, Contacts/Locations, Outcome Measures and Oversight
5 May 22, 2017 Study Status
6 June 7, 2017 Recruitment Status, Study Status and Contacts/Locations
7 June 22, 2017 Study Status
8 July 5, 2017 Study Status and Contacts/Locations
9 August 3, 2017 Study Status and Contacts/Locations
10 September 28, 2017 Study Status and Contacts/Locations
11 October 26, 2017 Study Status and Contacts/Locations
12 November 23, 2017 Study Status and Contacts/Locations
13 December 19, 2017 Study Status and Contacts/Locations
14 February 15, 2018 Study Status and Contacts/Locations
15 March 28, 2018 Study Status and Contacts/Locations
16 April 11, 2018 Study Status and Contacts/Locations
17 April 26, 2018 Contacts/Locations and Study Status
18 June 21, 2018 Study Status
19 July 16, 2018 Study Status
20 September 12, 2018 Contacts/Locations, Eligibility, Study Status, Outcome Measures, Arms and Interventions, Study Design, Study Description and Study Identification
21 November 8, 2018 Study Status and Contacts/Locations
22 July 18, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
23 September 16, 2019 Study Status and Contacts/Locations
24 June 26, 2020 Study Status, Outcome Measures, Document Section, Results and Study Identification
25 November 26, 2020 Study Status and References
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Study NCT02710890
Submitted Date:  March 14, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: EP0060
Brief Title: Study to Investigate Safety and Tolerability of Intravenous Lacosamide as Replacement of Oral Lacosamide in Children.
Official Title: A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Children (≥ 4 to < 17 Years of Age) With Epilepsy
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2016
Overall Status: Not yet recruiting
Study Start: October 2016
Primary Completion: May 2026 [Anticipated]
Study Completion: May 2026 [Anticipated]
First Submitted: March 9, 2016
First Submitted that
Met QC Criteria:
March 14, 2016
First Posted: March 17, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 14, 2016
Last Update Posted: March 17, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: UCB BIOSCIENCES, Inc.
Responsible Party: Sponsor
Collaborators: PRA Health Sciences
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) as replacement for oral LCM in pediatric subjects ≥ 4 to < 17 years of age with epilepsy.
Detailed Description:
Open or close this module Conditions
Conditions: Epilepsy
Keywords: Epilepsy
pediatric
intravenous
children
Lacosamide
VIMPAT®
seizure
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 75 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Lacosamide
Up to 3 age-based cohorts will be included: ≥12 to <17 years (cohort 1), ≥8 to <12 years (cohort 2), and ≥4 to <8 years (cohort 3). Enrollment will begin with subjects in the oldest age cohort (i.e., cohort 1) at the first infusion duration and continue sequentially with subjects in the younger age cohort (cohort 2, then cohort 3). After completion of a predefined subject set within each cohort, the Data Monitoring Committee will review safety and tolerability data to make recommendations for the progression to the next age-based cohort and possible shorter infusion duration.
Drug: Lacosamide

Pharmaceutical form: solution for infusion

Concentration: 10 mg/ml

Route of Administration: intravenous

Other Names:
  • Vimpat
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of subjects that withdraw due to treatment emergent adverse events during the study
[ Time Frame: During the intravenous treatment period (up to 5 days) ]

2. Number of subjects experiencing at least one treatment emergent adverse event during the study
[ Time Frame: During the intravenous treatment period (up to 5 days) ]

3. Number of subjects experiencing at least 1 injection-related treatment emergent adverse event during the study
[ Time Frame: During the intravenous treatment period (up to 5 days) ]

Open or close this module Eligibility
Minimum Age: 4 Years
Maximum Age: 16 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Subject is male or female from ≥4 to <17 years of age.
  • Subject is participating in a long-term, open-label study with Lacosamide (LCM) or is currently prescribed oral VIMPAT and needs to undergo a procedure, is admitted to an epilepsy monitoring unit (EMU) or health care facility, or other situations where intravenous (iv) administration of LCM is clinically appropriate.
  • Subject is an acceptable candidate for venipuncture and iv infusion.

Subjects who are participating in a long-term, open-label study with LCM must fulfill the following additional inclusion criteria:

  • Subject is currently enrolled in a long-term, open-label study, receiving oral LCM for the treatment of epilepsy.
  • Subject has been on a stable bid dosage regimen of oral LCM for the last 3 days in their long-term, open-label study.

Subjects who are currently prescribed oral VIMPAT and enroll directly into EP0060 must fulfill the following additional inclusion criteria:

  • Subject has been prescribed oral VIMPAT 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).
  • Subject has been prescribed oral VIMPAT for the treatment of epilepsy for at least 1 month prior to Screening and has not been prescribed or maintained on VIMPAT for the purposes of participating in EP0060. Prescribed oral VIMPAT dose must be stable for at least 7 days, and intake of the prescribed total daily dose confirmed for at least 3 days prior to first infusion.

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.
  • 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.
  • Subject does not have a diagnosis of epilepsy.
  • Subject is taking monoamine oxidase inhibitors (MAOIs).

Subjects who are participating in a long-term, open-label study with LCM are not permitted to enroll in EP0060 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.

Subjects who are currently prescribed oral VIMPAT are not permitted to directly enroll in EP0060 if any of the following additional criteria are met:

  • Subject has a medical condition that could reasonably be expected to interfere with drug distribution, metabolism, or excretion.
  • Subject has a known hypersensitivity to any component of the investigational medicinal product (IMP).
  • 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 an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level greater than or equal to 2 times the upper limit of normal (ULN), or 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 450ms).
  • Subject has hemodynamically significant heart disease (eg, heart failure).
  • Subject has an arrhythmic heart condition requiring medical therapy.
  • Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
  • Subject has only nonepileptic events, including psychogenic seizures, which could be confused with seizures. If both epileptic and nonepileptic events are present, epileptic events must be distinguished from nonepileptic phenomena.
  • Subject has been treated with felbamate for at least 12 months prior to entering EP0060 and has experienced any toxicity issues with this treatment. Note: Any subject who is currently treated with felbamate, and has received felbamate for a period of less than 12 months, is excluded from EP0060.
  • 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).
  • Subject has a known cardiac sodium channelopathy, such as Brugada syndrome.
Open or close this module Contacts/Locations
Central Contact Person: UCB Cares
Telephone: +1 887 822 Ext. 9493
Study Officials: UCB Cares
Study Director
+1 887 822 9493 (UCB)
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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