NCT00160550

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2001

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

November 26, 2013

Status Verified

September 1, 2009

Enrollment Period

3.8 years

First QC Date

September 8, 2005

Last Update Submit

November 25, 2013

Conditions

Generalized Convulsive Epilepsy

Keywords

Idiopathic Generalized Epilepsy, tonic-clonic seizuresLevetiracetam, Keppra

Outcome Measures

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 (4)

  • Reduction during the Treatment Period in PGTC seizure frequency

  • Percentage reduction during the Treatment Period in seizure days

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

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

Interventions

LevetiracetamDRUG

Eligibility Criteria

Age4 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 17625106RESULT

  • 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.

    PMID: 19327967RESULT

MeSH Terms

Conditions

Epilepsy, GeneralizedEpilepsy, Idiopathic GeneralizedSeizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 26, 2013

Record last verified: 2009-09