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Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

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ClinicalTrials.gov Identifier: NCT00150787
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy, Tonic-clonic Drug: LEVETIRACETAM Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
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.
Study Start Date : July 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources




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


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.

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

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

Keywords provided by UCB Pharma:
Monotherapy, epilepsy
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy, Tonic-Clonic
Epilepsy
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