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Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
This study has been completed.
First Received: September 9, 2005   Last Updated: September 14, 2009   History of Changes
Sponsor: UCB, Inc.
Information provided by: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00175903
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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
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

Study ID Numbers: N01175, EUDRACT NUMBER: 2004-001339-41
Study First Received: September 9, 2005
Last Updated: September 14, 2009
ClinicalTrials.gov Identifier: NCT00175903     History of Changes
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 - French Health Products Safety Agency;   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 and Social Development 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:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Brain Diseases
Neuroprotective Agents
Valproic Acid
Sensory System Agents
Therapeutic Uses
Analgesics
Nootropic Agents
Tranquilizing Agents
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Protective Agents
Pharmacologic Actions
Carbamazepine
Epilepsy
Analgesics, Non-Narcotic
Piracetam
GABA Agents
Etiracetam
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010