Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A