NCT00545012

Brief Summary

This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2000

Typical duration for phase_2

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

May 1, 2000

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2009

Enrollment Period

3 years

First QC Date

October 15, 2007

Last Update Submit

September 16, 2013

Conditions

Absence Seizures

Keywords

LevetiracetamKeppra

Outcome Measures

Primary Outcomes (1)

  • Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam

Interventions

LevetiracetamDRUG

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male/female 4-17 years old having participated in study N162 or in study N163
  • suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
  • expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration

You may not qualify if:

  • allergy/intolerance to pyrrolidine derivatives and/or excipients
  • use of \> 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns 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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

May 1, 2000

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

September 17, 2013

Record last verified: 2009-09