Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy. - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00150787

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 III

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

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

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam Carbamazepine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150787

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	N01093
Study First Received:	September 6, 2005
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00150787 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; 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 - French Health Products Safety Agency; Italy: Ministry of Health; Poland: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by UCB, Inc.:

Monotherapy, epilepsy
Levetiracetam
Keppra

Additional relevant MeSH terms:

Physiological Effects of Drugs
Psychotropic Drugs
Brain Diseases
Neuroprotective Agents
Sensory System Agents
Therapeutic Uses
Epilepsy, Tonic-Clonic
Analgesics
Nootropic Agents
Tranquilizing Agents
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Depressants

Antimanic Agents
Protective Agents
Pharmacologic Actions
Carbamazepine
Analgesics, Non-Narcotic
Epilepsy
Piracetam
Etiracetam
Peripheral Nervous System Agents
Epilepsy, Generalized
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010