A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital...
Date First Received: September 6, 2005
Last Updated: March 7, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2003
Overall Status: Completed
Estimated Enrollment: 250
Brief Summary
Official Title: “A Multicenter, Double-Blind, Follow-up Trial Evaluating the Long-Term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.”
Condition Keyword(s):
Intervention(s):
A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs
Study Type: Interventional
Study Design: Randomized, Double-Blind, Active Control, Parallel Assignment
Study Primary Completion Date: November 2005
Intervention(s) in this Clinical Trial
- Drug: LEVETIRACETAM
Outcome Measures for this Clinical Trial
Primary Measures
- Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
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 coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.
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
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
F Tonner, MD Study Director UCB
Related Publications
Citations Reporting Results
M. J. Brodie, E. Perucca, P. Ryvlin, E. Ben-Menachem, H.-J Meencke for the Levetiracetam Monotherapy Study Group Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy Neurology, Feb 2007; 68: 402 - 408.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150787
Study ID Number: N01093
ClinicalTrials.gov Identifier: NCT00150787
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Clinical Trials Authorship and Review
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