ClinicalTrials.gg
Sign In
CompletedNCT00160550Updated Nov 26, 2013

Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures

A Phase 3 interventional study of Levetiracetam in Generalized Convulsive Epilepsy, sponsored by UCB Pharma. Completed. Open to participants aged 4 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-26.

Primary conditionEpilepsy, Idiopathic GeneralizedRegistry: Epilepsy, GeneralizedReclassifiedWhy we changed it
Registry
Epilepsy, Generalized — the first condition term the registry derived for this study.
ClinicalTrials.gg
Epilepsy, Idiopathic Generalized
Why
  1. The study's title name Epilepsy, Idiopathic Generalized, a narrower term within Epilepsy, Generalized.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
4 Years to 65 Years
Sex
All
01

Study summary

This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.

02

Conditions studied

  • Generalized Convulsive Epilepsy

Browse trials for

Keywords

  • Idiopathic Generalized Epilepsy, tonic-clonic seizures
  • Levetiracetam, Keppra
03

In context

Epilepsy, Idiopathic Generalized Reclassified

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

This study's enrollment of 154 is above the median of 71 across 26 interventional studies indexed under Epilepsy, Idiopathic Generalized.

Browse Epilepsy, Idiopathic 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 →

Compared within Epilepsy, Idiopathic Generalized, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epilepsy, Generalized. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
4 Years to 65 Years
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

  • Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
  • Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
  • Absence of brain lesion documented on a CT scan or MRI.
  • An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
  • Male/female subject, >=4 or \<=65 years of age at Visit 1.
  • Subject on a stable dose of one or two AEDs during baseline.

Exclusion criteria

Exclusion Criteria:

  • Previous exposure to levetiracetam.
  • History of partial seizures.
  • History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
154 participants

Interventions

06

What researchers measure

Primary outcomes

  1. The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).

Secondary outcomes

  1. Reduction during the Treatment Period in PGTC seizure frequency

  2. Percentage reduction during the Treatment Period in seizure days

  3. Responder rates in PGTC seizure frequency, and in seizure days of all types.

  4. The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Berkovic SF, Knowlton RC, Leroy RF, Schiemann J, Falter U; Levetiracetam N01057 Study Group. Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy. Neurology. 2007 Oct 30;69(18):1751-60. doi: 10.1212/01.wnl.0000268699.34614.d3. Epub 2007 Jul 11. PubMed 17625106 ↗
  • Rosenfeld WE, Benbadis S, Edrich P, Tassinari CA, Hirsch E. Levetiracetam as add-on therapy for idiopathic generalized epilepsy syndromes with onset during adolescence: analysis of two randomized, double-blind, placebo-controlled studies. Epilepsy Res. 2009 Jul;85(1):72-80. doi: 10.1016/j.eplepsyres.2009.02.016. Epub 2009 Mar 26. PubMed 19327967 ↗
09

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
NCT00160550
Lead sponsor
UCB Pharma
First posted
Sep 12, 2005
Start date
Sep 2001
Primary completion
Jun 2005
Completion
Jun 2005
Last update
Nov 26, 2013

Study contacts

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

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Levetiracetam

Other studies in this condition

Epilepsy, Idiopathic Generalized →

Other studies from this sponsor

UCB Pharma →

Start the discussion