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Phase 3 Completed N=103 Treatment

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

Source: ClinicalTrials.gov NCT02710890 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: 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 — 12.5; 14.5 percentage of participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
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
12.5; 14.5
PRIMARY
Percentage of Participants That Withdrew Due to Adverse Events During the Study
0; 0

Eligibility Criteria

Inclusion Criteria

  • Male or female from >=1 month to =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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02710890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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