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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Pharmaceutical form: solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous
Ep0060 003
Birmingham, Alabama, United States
Ep0060 010
Little Rock, Arkansas, United States
Percentage of Participants With at Least One Adverse Event Reported Spontaneously by the Participant/or Caregiver (Including Parent/Legal Guardian) or Observed by the Investigator During the Study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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. 26 adverse events are reported splitting into at least 19 occurrences of individual pre-treatment emergent adverse events and 7 treatment emergent adverse events (TEAEs).
Time frame: From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Percentage of Participants That Withdrew Due to Adverse Events During the Study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants 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.
Time frame: From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
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Ep0060 008
Loxahatchee Groves, Florida, United States
Ep0060 009
Saint Paul, Minnesota, United States
Ep0060 014
Henderson, Nevada, United States
Ep0060 002
New Brunswick, New Jersey, United States
Ep0060 006
Akron, Ohio, United States
Ep0060 011
Cincinnati, Ohio, United States
Ep0060 005
Dallas, Texas, United States
Ep0060 007
San Antonio, Texas, United States
...and 13 more locations