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CompletedNCT00150735Updated Nov 26, 2013

Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

A Phase 3 interventional study of LEVETIRACETAM in Generalized Epilepsy, sponsored by UCB Pharma. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-11-26.

Sponsored by UCB Pharma (part of UCB S.A.) · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
580
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study summary

A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

02

Conditions studied

  • Generalized Epilepsy

Keywords

  • Monotherapy, epilepsy, Levetiracetam, Keppra.
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In context

Epilepsy, Generalized

39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.

This study's enrollment of 580 is above the median of 75 across 25 interventional studies indexed under Epilepsy, Generalized.

Browse Epilepsy, Generalized studies →

Lead sponsor

UCB Pharma is the lead sponsor of 242 studies on the registry; none are open to participants now.

Browse UCB Pharma studies →All UCB S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (≥16 years).

Exclusion criteria

Exclusion Criteria:

  • 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) at randomization.
05

Study design

Phase
Phase 3
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
580 participants

Interventions

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Proportion of subjects with one year seizure freedom; time to first seizure; safety.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; Levetiracetam Monotherapy Study Group. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007 Feb 6;68(6):402-8. doi: 10.1212/01.wnl.0000252941.50833.4a. PubMed 17283312 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00150735
Lead sponsor
UCB Pharma
First posted
Sep 8, 2005
Start date
Jun 2002
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Nov 26, 2013

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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