Clinical trial NCT01210690: Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
Official title: Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra® Oral Solution
Keppra® in Children
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming to day clinic for consultation by specialist

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.

Detailed description: This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months. Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days. The patients will be followed and their data will be collected until they reach the age of 13 months.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
timeFrame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Secondary outcomes:
measure: Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
timeFrame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit
timeFrame: From Baseline through the last Treatment Visit (maximum 12 months)
measure: Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit
timeFrame: From Baseline to the last Treatment Visit (maximum 12 months)
measure: Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit
timeFrame: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
measure: Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit
timeFrame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
measure: Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit
timeFrame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
measure: Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit
timeFrame: From Baseline to the last Treatment Visit (maximum 12 months)
measure: Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit
timeFrame: From Baseline to the last Treatment Visit (maximum 12 months)
measure: Global Evaluation Scale of the Psychomotor Development (GES)
timeFrame: From Baseline to the last Treatment Visit (maximum 12 months)
measure: Global Evaluation Scale of Epilepsy Severity (GES)
timeFrame: From Baseline to the last Treatment Visit (maximum time frame is 12 months)
measure: Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period
timeFrame: From Baseline through the last Treatment Visit (maximum 12 months)
Other outcomes:
Locations:
city: Amiens
country: France
facility: 012
city: Bron
country: France
facility: 010
city: Paris
country: France
facility: 011
city: Berlin
country: Germany
facility: 027
city: Bielefeld
country: Germany
facility: 024
city: Heidelberg
country: Germany
facility: 026
city: Kehl Kork
country: Germany
facility: 021
city: Kiel
country: Germany
facility: 023
city: Muenster
country: Germany
facility: 022
city: Athens
country: Greece
facility: 072
city: Patras
country: Greece
facility: 071
city: Bologna
country: Italy
facility: 037
city: Calambrone
country: Italy
facility: 031
city: Milano
country: Italy
facility: 032
city: Roma
country: Italy
facility: 034
city: Verona
country: Italy
facility: 035
city: Gdansk
country: Poland
facility: 065
city: Lodz
country: Poland
facility: 064
city: Szczecin
country: Poland
facility: 063
city: Warszawa
country: Poland
facility: 062
city: Barcelona
country: Spain
facility: 043
city: Madrid
country: Spain
facility: 044
city: Madrid
country: Spain
facility: 045
city: Murcia
country: Spain
facility: 046
city: Birmingham
country: United Kingdom
facility: 057
city: Liverpool
country: United Kingdom
facility: 052
city: London
country: United Kingdom
facility: 051
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: