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 (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00175903
First received: September 9, 2005
Last updated: March 12, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Levetiracetam
Drug: Carbamazepine Controlled Release (CBZ-CR)
Drug: Valproate Extended Release
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 Pharma:

Primary Outcome Measures:
  • Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ] [ Designated as safety issue: No ]
  • The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ] [ Designated as safety issue: No ]
  • The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ] [ Designated as safety issue: No ]
  • The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ] [ Designated as safety issue: No ]
  • The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ] [ Designated as safety issue: No ]
  • Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ] [ Designated as safety issue: No ]
  • Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ] [ Designated as safety issue: No ]
  • Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ] [ Designated as safety issue: No ]
  • Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ] [ Designated as safety issue: No ]
  • Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ] [ Designated as safety issue: No ]
  • Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
Experimental: Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Drug: Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Active Comparator: Older Antepileptic Drugs
Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
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.

  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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175903     History of Changes
Other Study ID Numbers: N01175, 2004-001339-41
Study First Received: September 9, 2005
Last Updated: March 12, 2015
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 Pharma:
Newly Diagnosed Epilepsy
Levetiracetam
Keppra
Carbamazepine
Valproate

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

ClinicalTrials.gov processed this record on July 28, 2015