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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210690
• Other study ID #: N01357
• Secondary ID: 2009-017333-21
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: November 18, 2014
• Start date: January 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: The Italian Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Greece: National Organization of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 11 Months

Eligibility

Inclusion Criteria:

• diagnosis of epilepsy

• being treated with Keppra® Oral Solution

• aged between 1 month and 11 months inclusive at study baseline

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
France	012	Amiens
France	010	Bron
France	011	Paris
Germany	027	Berlin
Germany	024	Bielefeld
Germany	026	Heidelberg
Germany	021	Kehl Kork
Germany	023	Kiel
Germany	022	Muenster
Greece	072	Athens
Greece	071	Patras
Italy	037	Bologna
Italy	031	Calambrone
Italy	032	Milano
Italy	034	Roma
Italy	035	Verona
Poland	065	Gdansk
Poland	064	Lodz
Poland	063	Szczecin
Poland	062	Warszawa
Spain	043	Barcelona
Spain	044	Madrid
Spain	045	Madrid
Spain	046	Murcia
United Kingdom	057	Birmingham
United Kingdom	052	Liverpool
United Kingdom	051	London

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

France,  Germany,  Greece,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up	Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) 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-weeks safety follow-up)	No
Secondary	Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit	Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).	From Baseline through the last Treatment Visit (maximum 12 months)	No
Secondary	Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit	Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.	From Baseline to the last Treatment Visit (maximum 12 months)	No
Secondary	Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit	For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.	From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)	No
Secondary	Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit	For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.	From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)	No
Secondary	Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit	For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.	From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)	No
Secondary	Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit	Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).; The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs.	From Baseline to the last Treatment Visit (maximum 12 months)	No
Secondary	Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit	The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.	From Baseline to the last Treatment Visit (maximum 12 months)	No
Secondary	Global Evaluation Scale of the Psychomotor Development (GES)	Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options: 7=Marked improvement; 6=Moderate improvement; 5=Slight improvement; 4=No Change; 3=Slight worsening; 2=Moderate worsening; 1=Marked worsening; As a variant of this variable, a 3-class variable was derived as follows; "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved."; "No change" was defined as "Stable."; "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."	From Baseline to the last Treatment Visit (maximum 12 months)	No
Secondary	Global Evaluation Scale of Epilepsy Severity (GES)	Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options: 7=Marked improvement; 6=Moderate improvement; 5=Slight improvement; 4=No Change; 3=Slight worsening; 2=Moderate worsening; 1=Marked worsening; As a variant of this variable, a 3-class variable was derived as follows; "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved."; "No change" was defined as "Stable."; "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."	From Baseline to the last Treatment Visit (maximum time frame is 12 months)	No
Secondary	Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period	Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).	From Baseline through the last Treatment Visit (maximum 12 months)	No

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