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

Sponsored by:	UCB
Information provided by:	UCB
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

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

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

U.S. FDA Resources

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.

Further study details as provided by UCB:

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

Investigators

Study Director:

SONJA BUYLE, MD

UCB

More Information

Study ID Numbers:	N01175, EUDRACT NUMBER: 2004-001339-41
Study First Received:	September 9, 2005
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00175903
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: National Agency for Medicines; 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:

NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, CARBAMAZEPINE, VALPROATE

Study placed in the following topic categories:

Carbamazepine
Epilepsy
Central Nervous System Diseases

Etiracetam
Brain Diseases
Valproic Acid

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents

Pharmacologic Actions
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
GABA Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009