Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting...
Brief Summary
Official Title: “A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.”
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2007
Intervention(s) in this Clinical Trial
- Drug: LEVETIRACETAM
Outcome Measures for this Clinical Trial
Primary Measures
- Around 4 years of Safety assessment of levetiracetam via Adverse Events reporting,
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past 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
- Subjects having participated in the previous double-blind monotherapy trial (N01061 or N01093).
- Male/female subjects (≥ 16 years).
Exclusion Criteria:
- Need for an additional AED.
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 Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150813
Study ID Number: N01127
ClinicalTrials.gov Identifier: NCT00150813
Health Authority: Czech Republic: State Institute for Drug Control
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00150813
