Brief Summary

The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.

Trial Health

On Track

Trial Health Score

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

Enrollment

101

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach

7 countries

27 active sites

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

2.8 years study duration

First Submitted

Initial submission to the registry

September 23, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed

3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

1 year until next milestone

Results Posted

Study results publicly available

November 19, 2014

Completed

Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

September 23, 2010

Results QC Date

November 11, 2014

Last Update Submit

November 18, 2014

Conditions

Epilepsy

Keywords

LevetiracetamKeppra® Oral SolutionKeppra® in Children

Outcome Measures

Primary Outcomes (1)

Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Secondary Outcomes (11)

Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit
From Baseline through the last Treatment Visit (maximum 12 months)
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit
From Baseline to the last Treatment Visit (maximum 12 months)
Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit
From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit
From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
+6 more secondary outcomes

Study Arms (1)

Patients, 1 - 11 months old, prescribed Keppra® oral solution

Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who are between 1 and 11 months old. The patients will be followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, is made independently by the physician in the regular course of practice and is not influenced by the study protocol.

Eligibility Criteria

Age1 Month - 11 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

Patients coming to day clinic for consultation by specialist

You may qualify if:

diagnosis of epilepsy
being treated with Keppra® Oral Solution
aged between 1 month and 11 months inclusive at study baseline

You may not qualify if:

none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

UCB Pharmalead

Study Sites (27)

012

Amiens, France

Location

010

Bron, France

Location

011

Paris, France

Location

027

Berlin, Germany

Location

024

Bielefeld, Germany

Location

026

Heidelberg, Germany

Location

021

Kehl Kork, Germany

Location

023

Kiel, Germany

Location

022

Münster, Germany

Location

072

Athens, Greece

Location

071

Pátrai, Greece

Location

037

Bologna, Italy

Location

031

Calambrone, Italy

Location

032

Milan, Italy

Location

034

Roma, Italy

Location

035

Verona, Italy

Location

065

Gdansk, Poland

Location

064

Lodz, Poland

Location

063

Szczecin, Poland

Location

062

Warsaw, Poland

Location

043

Barcelona, Spain

Location

044

Madrid, Spain

Location

045

Madrid, Spain

Location

046

Murcia, Spain

Location

057

Birmingham, United Kingdom

Location

052

Liverpool, United Kingdom

Location

051

London, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title: UCB Cares
Organization: UCB

Study Officials

UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 28, 2010

Study Start

January 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 19, 2014

Results First Posted

November 19, 2014

Record last verified: 2014-11

Locations

PL(4)ES(4)DE(6)IT(5)FR(3)GR(2)GB(3)

Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Patients, 1 - 11 months old, prescribed Keppra® oral solution

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Patients, 1 - 11 months old, prescribed Keppra® oral solution

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations