Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00150787
First received: September 6, 2005
Last updated: November 25, 2013
Last verified: September 2009
  Purpose

A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs


Condition Intervention Phase
Epilepsy, Tonic-clonic
Drug: LEVETIRACETAM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs

Estimated Enrollment: 250
Study Start Date: July 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Subjects with a confirmed diagnosis of epilepsy.
  • Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
  • Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion Criteria:

  • Need for an additional AED.
  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: NCT00150787

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

Additional Information:
Publications:
M. J. Brodie, E. Perucca, P. Ryvlin, E. Ben-Menachem, H.-J Meencke for the Levetiracetam Monotherapy Study Group Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy Neurology, Feb 2007; 68: 402 - 408.

ClinicalTrials.gov Identifier: NCT00150787     History of Changes
Other Study ID Numbers: N01093
Study First Received: September 6, 2005
Last Updated: November 25, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Spain: Ministry of Health and Consumption
Netherlands: Medicines Evaluation Board (MEB)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
South Africa: Medicines Control Council
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Poland: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by UCB Pharma:
Monotherapy, epilepsy
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Tonic-Clonic
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Carbamazepine
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
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 September 11, 2014