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Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

NCT02477839 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2021-07-01

Study results available
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Summary

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

Conditions

  • Epilepsy With Partial-onset Seizures

Interventions

DRUG

Lacosamide

Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral

OTHER

Placebo

Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral

Sponsors & Collaborators

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
47 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-05
Primary Completion
2020-05-28
Completion
2020-05-28

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • China
  • Croatia
  • Czechia
  • France
  • Georgia
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Moldova
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

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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 NCT02477839 on ClinicalTrials.gov