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Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

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.
 
ClinicalTrials.gov Identifier: NCT00643500
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

  • to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
  • to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Levetiracetam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Study Start Date : January 2002
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003





Primary Outcome Measures :
  1. Adverse event rates, seizure counts and quality of life. [ Time Frame: 16 week treatment period ]


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:

  • Male and female older than 16 years;
  • Epilepsy with partial onset seizures, with or without secondary generalization;
  • At least one concomitant marketed anti-epileptic drug

Exclusion Criteria:

  • Safety reasons

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): NCT00643500


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
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Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00643500    
Other Study ID Numbers: N01033
First Posted: March 26, 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
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents