Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: September 6, 2005
Last updated: November 25, 2013
Last verified: July 2010
A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

Condition Intervention Phase
Generalized Epilepsy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.

Secondary Outcome Measures:
  • Proportion of subjects with one year seizure freedom; time to first seizure; safety.

Estimated Enrollment: 580
Study Start Date: June 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Subjects with newly or recently diagnosed epilepsy having experienced 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. The discrimination between IC and IIE is not requested for inclusion.
  • Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
  • Subjects with a confirmed diagnosis of epilepsy.
  • Male/female subjects (≥16 years).

Exclusion Criteria:

  • History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
  • History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. < 20 minutes, with or without function regained between 2 ictal events.
  • History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.
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Please refer to this study by its identifier: NCT00150735

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

Additional Information:
Publications: Identifier: NCT00150735     History of Changes
Other Study ID Numbers: N01061 
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
Sweden: Medical Products Agency
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

Keywords provided by UCB Pharma:
Monotherapy, epilepsy, Levetiracetam, Keppra.

Additional relevant MeSH terms:
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroprotective Agents
Nootropic Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016