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

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 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:

MedlinePlus related topics: Epilepsy

Drug Information available for: Valproic acid Carbamazepine Valproate Sodium Divalproex sodium Levetiracetam

U.S. FDA Resources

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

No publications provided

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:	September 14, 2009
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:

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 May 24, 2012