Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy, Tonic-Clonic
Intervention: LEVETIRACETAM (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
F Tonner, MD, Study Director, Affiliation: UCB
Summary
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
Clinical Details
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.
Study design: Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: July 2003
Ending date: November 2005
Last updated: March 7, 2008
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