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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00175903
First received: September 9, 2005
Last updated: December 5, 2013
Last verified: September 2009
  Purpose

Open label, multicenter, international, randomized, parallel group, phase IIIb study comparing the efficacy and safety of levetiracetam to two standard antiepileptic drugs (CBZ and VPA) in patients with newly diagnosed epilepsy in a clinical practice setting.


Condition Intervention Phase
EPILEPSY
Drug: LEVETIRACETAM (UCB)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • TIME TO WITHDRAWAL OF STUDY MEDICATION AS A COMBINED MEASURE OF EFFICACY AND SAFETY

Secondary Outcome Measures:
  • EFFICACY:RETENTION RATE; SEIZURE FREEDOM AT 6 AND 12 MONTHS; TIME TO FIRST SEIZURE.

Enrollment: 1701
Study Start Date: February 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of epilepsy (all types of seizures) was made during the past year.
  • Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months.
  • Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method.

Exclusion Criteria:

  • Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial.
  • Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial.
  • Pregnant or lactating women.
  • Presence of known pseudoseizures within the last year.
  • Uncountable seizures (clusters) or history of convulsive status epilepticus.
  • Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs.
  • History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years.
  • Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
  • Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175903

  Show 231 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00175903     History of Changes
Other Study ID Numbers: N01175, EUDRACT NUMBER: 2004-001339-41
Study First Received: September 9, 2005
Last Updated: December 5, 2013
Health Authority: Austria: Federal Ministry for Health and Women
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Romania: State Institute for Drug Control

Keywords provided by UCB, Inc.:
NEWLY DIAGNOSED EPILEPSY
LEVETIRACETAM
KEPPRA
CARBAMAZEPINE
VALPROATE

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Valproic Acid
Carbamazepine
Piracetam
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014