NCT00631150

Brief Summary

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds 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
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2003

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

March 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

November 15, 2013

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

February 27, 2008

Last Update Submit

November 14, 2013

Conditions

Epilepsy

Keywords

LevetiracetamKeppra

Outcome Measures

Primary Outcomes (1)

  • Safety and the tolerability of Keppra in a broad population of patients.

Secondary Outcomes (1)

  • Obtain further information about optimal daily dose.

Interventions

Levetiracetam (Keppra)DRUG

Eligibility Criteria

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

You may qualify if:

  • partial onset seizures with or without secondary generalisation with epilepsy.

You may not qualify if:

  • hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain 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 27, 2008

First Posted

March 7, 2008

Study Start

March 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

November 15, 2013

Record last verified: 2009-09