Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00150735

Purpose

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	Drug: LEVETIRACETAM	Phase III

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

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam Carbamazepine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Double-Blind, Active Control, Parallel Assignment
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

Further study details as provided by UCB:

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)

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150735

Sponsors and Collaborators

UCB

Investigators

Study Director:

Françoise Tonner, M.D

Unaffiliated

More Information

Publications of Results:

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.

Study ID Numbers:	N01061
Study First Received:	September 6, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00150735
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; 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: National Agency for Medicines; South Africa: Medicines Control Council; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Poland: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by UCB:

Monotherapy, epilepsy, Levetiracetam, Keppra.

Study placed in the following topic categories:

Carbamazepine
Epilepsy
Seizures
Piracetam

Central Nervous System Diseases
Etiracetam
Brain Diseases
Epilepsy, Generalized

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009