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Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00319605
First received: April 28, 2006
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire.


Condition Intervention Phase
Epilepsy
 Drug: Levetiracetam
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam (Keppra®) (SOLUCION Study)

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Estimated Enrollment: 600
Study Start Date: April 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study populaton is defined. See Eligibility Criteria.

Criteria

Inclusion Criteria:

  • Patients 16 years old or older diagnosed with partial epilepsy with or without generalization receiving levetiracetam oral solution for at least 28 days before the study

Exclusion Criteria:

  • Patients with disturbances of the sense of taste and smell that can interfere with the assessment of the parameters of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319605

  Show 54 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Helena Marin Muñoz, MD UCB, Inc.
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00319605     History of Changes
Other Study ID Numbers: N01242
Study First Received: April 28, 2006
Last Updated: May 24, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by UCB, Inc.:
Cross sectional study
acceptability
levetiracetam
oral solution
Keppra

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013