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Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

NCT00175903 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1701

Last updated 2015-03-17

No results posted yet for this study

Summary

Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

Conditions

Interventions

DRUG

Levetiracetam

Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

DRUG

Carbamazepine Controlled Release (CBZ-CR)

Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.

DRUG

Valproate Extended Release

Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00175903 on ClinicalTrials.gov