Monotherapy With Levetiracetam in Newly Diagnosed 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: Generalized Epilepsy
Intervention: LEVETIRACETAM (Drug)
Phase: Phase 3
Sponsored by: UCB
Official(s) and/or principal investigator(s):
FranÃ§oise Tonner, M.D, Study Director, Affiliation: Unaffiliated
A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used
as monotherapy in subjects (â¥ 16 years) newly or recently diagnosed as suffering from
epilepsy, and experiencing partial or generalized tonic-clonic seizures.
Official title: A Multicenter, Double-Blind, Randomized, Parallel Group, Positive-Controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-Clonic Seizures
Study design: Non-Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.
Secondary outcome: Proportion of subjects with one year seizure freedom; time to first seizure; safety.
Minimum age: 16 Years.
Maximum age: N/A.
- Subjects with newly or recently diagnosed epilepsy having experienced 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. The discrimination between IC and
IIE is not requested for inclusion.
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the
year preceding randomization out of which at least 1 unprovoked seizure in the 3
months preceding randomization.
- Subjects with a confirmed diagnosis of epilepsy.
- Male/female subjects (â¥16 years).
- History or presence of seizures of other types than partial (IA, IB, IC, with clear
focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
- History or presence of seizures occurring only in clustered patterns, defined as
repeated seizures occurring over a short period of time, i. e. < 20 minutes, with or
without function regained between 2 ictal events.
- History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE)
Locations and Contacts
Starting date: June 2002
Ending date: July 2005
Last updated: March 7, 2008