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Trial record 1 of 1 for:    NCT00631150
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A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

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ClinicalTrials.gov Identifier: NCT00631150
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam (Keppra) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Study Start Date : March 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and the tolerability of Keppra in a broad population of patients.

Secondary Outcome Measures :
  1. Obtain further information about optimal daily dose.

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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion Criteria:

  • hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.
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): NCT00631150


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00631150    
Other Study ID Numbers: N01035
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Levetiracetam
Keppra
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Levetiracetam
Anticonvulsants
Nootropic Agents