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

• ClinicalTrials.gov Identifier: NCT01210690
• Recruitment Status: Completed
• First Posted: September 28, 2010
• Results First Posted: November 19, 2014
• Last Update Posted: November 19, 2014
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

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.

Condition or disease
Epilepsy

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 101 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Start Date: January 2011
• Actual Primary Completion Date: November 2013
• Actual Study Completion Date: November 2013

Groups and Cohorts

Group/Cohort

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.

Outcome Measures

Primary Outcome Measures :

1. Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit [ Time Frame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up) ]
   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).

Secondary Outcome Measures :

1. Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up [ Time Frame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks 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).
2. Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit [ Time Frame: From Baseline through the last Treatment Visit (maximum 12 months) ]
   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).
3. Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit [ Time Frame: From Baseline to the last Treatment Visit (maximum 12 months) ]
   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.
4. Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit [ Time Frame: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up) ]
   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.
5. Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit [ Time Frame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up) ]
   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.
6. Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit [ Time Frame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up) ]
   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.
7. Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit [ Time Frame: From Baseline to the last Treatment Visit (maximum 12 months) ]

   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.

8. Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit [ Time Frame: From Baseline to the last Treatment Visit (maximum 12 months) ]
   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.
9. Global Evaluation Scale of the Psychomotor Development (GES) [ Time Frame: From Baseline to the last Treatment Visit (maximum 12 months) ]

   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."
10. Global Evaluation Scale of Epilepsy Severity (GES) [ Time Frame: From Baseline to the last Treatment Visit (maximum time frame is 12 months) ]

    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."
11. Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period [ Time Frame: From Baseline through the last Treatment Visit (maximum 12 months) ]
    Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 11 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients coming to day clinic for consultation by specialist

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

Contacts and Locations

Locations

France

012

Amiens, France

010

Bron, France

011

Paris, France

Germany

027

Berlin, Germany

024

Bielefeld, Germany

026

Heidelberg, Germany

021

Kehl Kork, Germany

023

Kiel, Germany

022

Muenster, Germany

Greece

072

Athens, Greece

071

Patras, Greece

Italy

037

Bologna, Italy

031

Calambrone, Italy

032

Milano, Italy

034

Roma, Italy

035

Verona, Italy

Poland

065

Gdansk, Poland

064

Lodz, Poland

063

Szczecin, Poland

062

Warszawa, Poland

Spain

043

Barcelona, Spain

044

Madrid, Spain

045

Madrid, Spain

046

Murcia, Spain

United Kingdom

057

Birmingham, United Kingdom

052

Liverpool, United Kingdom

051

London, United Kingdom

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT01210690
• Other Study ID Numbers: N01357; 2009-017333-21 ( EudraCT Number )
• First Posted: September 28, 2010
• Results First Posted: November 19, 2014
• Last Update Posted: November 19, 2014
• Last Verified: November 2014

Keywords provided by UCB Pharma:

Levetiracetam; Keppra® Oral Solution; Keppra® in Children

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases