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

NCT02710890 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-02-23

Study results available
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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.

Conditions

Interventions

DRUG

Lacosamide

Pharmaceutical form: solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous

Sponsors & Collaborators

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 8445992273 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2019-06-28
Completion
2019-06-28
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Italy
  • Poland
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710890 on ClinicalTrials.gov