NCT00643500

Brief Summary

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

  • to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
  • to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2002

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

January 1, 2002

Completed
1.3 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
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

November 15, 2013

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

February 21, 2008

Last Update Submit

November 14, 2013

Conditions

Epilepsy, Partial

Keywords

LevetiracetamKeppra

Outcome Measures

Primary Outcomes (1)

  • Adverse event rates, seizure counts and quality of life.

    16 week treatment period

Interventions

LevetiracetamDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female older than 16 years;
  • Epilepsy with partial onset seizures, with or without secondary generalization;
  • At least one concomitant marketed anti-epileptic drug

You may not qualify if:

  • Safety reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 21, 2008

First Posted

March 26, 2008

Study Start

January 1, 2002

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

November 15, 2013

Record last verified: 2009-09