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A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

NCT01964560 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2022-10-25

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

Conditions

Interventions

DRUG

Lacosamide

Pharmaceutical form: oral solution Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day) Route of administration: oral use

DRUG

Lacosamide

Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use

Sponsors & Collaborators

  • UCB Biopharma SRL

    collaborator INDUSTRY

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-08-13
Primary Completion
2022-04-13
Completion
2022-04-13

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • China
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • France
  • Georgia
  • Greece
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Moldova
  • Montenegro
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT01964560 on ClinicalTrials.gov