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...
Date First Received: April 28, 2006
Last Updated: March 7, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2006
Overall Status: Completed
Estimated Enrollment: 600
Brief Summary
Official Title: “Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam (Keppra®) (SOLUCION Study)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Observational
Study Design: Retrospective
Study Primary Completion Date: July 2006
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Helena Marin Muñoz, MD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00319605
Study ID Number: N01242
ClinicalTrials.gov Identifier: NCT00319605
Health Authority: Spain: Spanish Agency of Medicines
Clinical Trials Authorship and Review
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