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A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age

NCT03340064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-07-23

Study results available
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Summary

This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.

Conditions

  • Partial Seizures

Interventions

DRUG

Levetiracetam

levetiracetam dry syrup 50% for oral administration and levetiracetam solution for infusion (100 mg/mL)

Sponsors & Collaborators

  • UCB Japan Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2021-06-01
Completion
2023-07-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT03340064 on ClinicalTrials.gov