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Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150787
First Posted: September 8, 2005
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150787


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00150787     History of Changes
Other Study ID Numbers: N01093
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 26, 2013
Last Verified: September 2009

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
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action