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Trial record 1 of 1 for:    NCT00150735
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Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

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ClinicalTrials.gov Identifier: NCT00150735
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Epilepsy Drug: LEVETIRACETAM Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 580 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Proportion of subjects with one year seizure freedom; time to first seizure; safety.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00150735


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

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ClinicalTrials.gov Identifier: NCT00150735    
Other Study ID Numbers: N01061
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: July 2010
Keywords provided by UCB Pharma:
Monotherapy, epilepsy, Levetiracetam, Keppra.
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents