Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 236 for:    LEVETIRACETAM

A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340064
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Brief Summary:
This is a study to confirm the efficacy of Levetiracetam as adjunctive treatment in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.

Condition or disease Intervention/treatment Phase
Partial Seizures Drug: Levetiracetam Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Multicenter Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Levetiracetam

Subjects aged 1 month to <6 months will be started on LEV 14 mg/kg/day at Visit 3. The dose may be increased by LEV 14 mg/kg/day for subjects aged 1 month to <6 months at 2-week intervals to a maximum dose of 42 mg/kg/day. Subjects aged 6 months to <4 years will be started on LEV 20 mg/kg/day at Visit 3. The dose may be increased by LEV 20 mg/kg/day at 2-week intervals to a maximum dose of 60 mg/kg/day.

At Visit 6, subjects may enter the Second Period or enter the Down-Titration Period followed by a Safety Follow-Up Period. Subjects who do not enter the Second Period will be down-titrated. The dose will be decreased by LEV 14 mg/kg/day for subjects aged 1 month to <6 months or by LEV 20 mg/kg/day for subjects aged 6 months to <4 years at 2-week intervals to 0 mg/kg/day.

Drug: Levetiracetam
Levetiracetam dry syrup 50% for oral administration and Levetiracetam solution for infusion (100 mg/mL).
Other Names:
  • Keppra
  • E-Keppra




Primary Outcome Measures :
  1. Percent change in average daily frequency (ADF) of partial seizure frequency monitored by the 48 h video-EEG at Week 6 [ Time Frame: From Selection Period to Week 6 ]

    This Variable will be tested in the First Period for subjects on adjunctive therapy.

    Partial seizure count will be based on electrographic seizures with or without clinical correlate depending upon age as specified below. Partial seizure frequency for subjects aged >=1 month to <=6 months will be based on electrographic seizures. Partial seizure frequency for subjects aged >6 months to <4 years will be based on electrographic seizures with an accompanying clinical correlate. Electrographic seizures are defined as recognizable ictal patterns on an electroencephalogram (EEG) involving >=2 contiguous electrodes. The seizures are initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge lasting a total of >10 seconds.



Secondary Outcome Measures :
  1. Percent change in ADF of partial seizure frequency monitored by the 48 h video-EEG at Week 2 [ Time Frame: From Selection Period to Week 2 ]

    This Variable will be tested in the First Period for subjects on adjunctive therapy.

    Partial seizure count will be based on electrographic seizures with or without clinical correlate depending upon age as specified below. Partial seizure frequency for subjects aged >=1 month to <=6 months will be based on electrographic seizures. Partial seizure frequency for subjects aged >6 months to <4 years will be based on electrographic seizures with an accompanying clinical correlate. Electrographic seizures are defined as recognizable ictal patterns on an EEG involving >=2 contiguous electrodes. The seizures are initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge lasting a total of >10 seconds.


  2. Percent change in ADF of partial seizure frequency grouped into categories based on the Evaluation Period 48 h video-EEG compared to the Selection Period 48 h video-EEG at Week 2 [ Time Frame: From Selection Period to Week 2 ]

    This Variable will be tested in the First Period for subjects on adjunctive therapy.

    The change of seizure frequency will be presented in following categories: <0%, 0% to <25%, 25% to <50%, >=50%, >=75%, and 100%


  3. Percent change in ADF of partial seizure frequency grouped into categories based on the Evaluation Period 48 h video-EEG compared to the Selection Period 48 h video-EEG at Week 6 [ Time Frame: From Selection Period to Week 6 ]

    This Variable will be tested in the First Period for subjects on adjunctive therapy.

    The change of seizure frequency will be presented in following categories: <0%, 0% to <25%, 25% to <50%, >=50%, >=75%, and 100%


  4. Percent change in ADF of electro-clinical partial seizure frequency at Week 2 [ Time Frame: From Selection Period to Week 2 ]
    This Variable will be tested in the First Period for subjects on adjunctive therapy.

  5. Percent change in ADF of electro-clinical partial seizure frequency at Week 6 [ Time Frame: From Selection Period to Week 6 ]
    This Variable will be tested in the First Period for subjects on adjunctive therapy.

  6. Percent change in partial seizure frequency per week monitored by the patient diary at Week 2 [ Time Frame: From Baseline to Week 2 ]
    This Variable will be tested in the First Period for subjects on adjunctive therapy.

  7. Percent change in partial seizure frequency per week monitored by the patient diary at Week 4 [ Time Frame: From Baseline to Week 4 ]
    This Variable will be tested in the First Period for subjects on adjunctive therapy.

  8. Percent change in partial seizure frequency per week monitored by the patient diary at Week 6 [ Time Frame: From Baseline to Week 6 ]
    This Variable will be tested in the First Period for subjects on adjunctive therapy.

  9. Percent change in partial seizure frequency per week monitored by the patient diary [ Time Frame: From Baseline during the combined Evaluation or Dose Adjustment and Maintenance Periods for each Analysis Visit (Week 0 up to Week 216) ]

    This Variable will be tested in the Combined First and Second Period for subjects on adjunctive therapy who are not and who are 48 h video-EEG failures.

    The change of seizure frequency per week will be monitored for each Analysis Visit at Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36 and then every 12 weeks.


  10. Percent change in partial seizure frequency per week monitored by the patient diary grouped into categories [ Time Frame: From Baseline during the combined Evaluation or Dose Adjustment and Maintenance Periods for each Analysis Visit (Week 0 up to Week 216) ]

    This Variable will be tested in the Combined First and Second Period for subjects on adjunctive therapy who are not and who are 48 h video-EEG failures.

    The change of seizure frequency will be presented in following categories: <0%, 0% to <25%, 25% to <50%, >=50%, >=75%, and 100% The change of seizure frequency per week will be monitored for each Analysis Visit at Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36 and then every 12 weeks.


  11. Percent change in ADF of partial seizure frequency monitored by the 48 h video-EEG at Week 2 [ Time Frame: From Selection Period to Week 2 ]
    This Variable will be tested in the First Period for subjects on monotherapy.

  12. Percent change in ADF of partial seizure frequency monitored by the 48 h video-EEG at Week 6 [ Time Frame: From Selection Period to Week 6 ]
    This Variable will be tested in the First Period for subjects on monotherapy.

  13. Percent change in ADF of partial seizure frequency based on the Evaluation Period 48 h video-EEG compared to the Selection Period 48 h video-EEG grouped into categories at Week 2 [ Time Frame: From Selection Period to Week 2 ]

    This Variable will be tested in the First Period for subjects on monotherapy.

    The change in average daily frequency of partial seizure frequency will be presented in following categories: <0%, 0% to <25%, 25% to <50%, >=50%, >=75%, and 100%


  14. Percent change in ADF of partial seizure frequency based on the Evaluation Period 48 h video-EEG compared to the Selection Period 48 h video-EEG grouped into categories at Week 6 [ Time Frame: From Selection Period to Week 6 ]

    This Variable will be tested in the First Period for subjects on monotherapy.

    The change in average daily frequency of partial seizure frequency will be presented in following categories: <0%, 0% to <25%, 25% to <50%, >=50%, >=75%, and 100%


  15. Percent change in ADF of electro-clinical partial seizure frequency at Week 2 [ Time Frame: From Selection Period to Week 2 ]
    This Variable will be tested in the First Period for subjects on monotherapy

  16. Percent change in ADF of electro-clinical partial seizure frequency at Week 6 [ Time Frame: From Selection Period to Week 6 ]
    This Variable will be tested in the First Period for subjects on monotherapy.

  17. Percent change in partial seizure frequency per week monitored by the patient diary [ Time Frame: From Baseline during the combined Evaluation or Dose Adjustment and Maintenance Periods for each Analysis Visit (Week 0 up to Week 216) ]

    This Variable will be tested in the Combined First and Second Period for subjects on monotherapy who are not and who are 48 h video-EEG failures.

    The change of seizure frequency per week will be monitored for each Analysis Visit at Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36 and then every 12 weeks.


  18. Percent change in partial seizure frequency per week monitored by the patient diary grouped into categories [ Time Frame: From Baseline during the combined Evaluation or Dose Adjustment and Maintenance Periods for each Analysis Visit (Week 0 up to Week 216) ]

    This Variable will be tested in the Combined First and Second Period for subjects on monotherapy who are not and who are 48 h video-EEG failures.

    The change of seizure frequency will be presented in following categories: <0%, 0% to <25%, 25% to <50%, >=50%, >=75%, and 100% The change of seizure frequency per week will be monitored for each Analysis Visit at Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36 and then every 12 weeks.


  19. Incidence of Treatment Emergent Adverse Events (TEAEs) during the First Period [ Time Frame: From Selection Period to Week 6 ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  20. Incidence of SAEs during the First Period [ Time Frame: From Selection Period to Week 6 ]

    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization
    • Is a congenital anomaly or birth defect
    • Is as infection that requires treatment parenteral antibiotics
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

  21. Incidence of TEAEs led to discontinuation during the First Period [ Time Frame: From Selection Period to Week 6 ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  22. Incidence of TEAEs during the Combined First and Second Period [ Time Frame: During Evaluation or Dose Adjustment and Maintenance Periods (Week 0 up to Week 218) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  23. Incidence of SAEs during the Combined First and Second Period [ Time Frame: During Evaluation or Dose Adjustment and Maintenance Periods (Week 0 up to Week 218) ]

    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization
    • Is a congenital anomaly or birth defect
    • Is as infection that requires treatment parenteral antibiotics
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

  24. Incidence of TEAEs leading to discontinuation during the Combined First and Second Period [ Time Frame: During Evaluation or Dose Adjustment and Maintenance Periods (Week 0 up to Week 218) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have a diagnosis of epilepsy with partial onset seizures whether or not secondarily generalized
  • Male or female from 1 month to <4 years of age. Pre-term infants aged <1 year are to be stratified into an appropriate age category using the best estimate of their corrected gestational age
  • For subjects on adjunctive therapy, subject must be on a stable antiepileptic drug (AED) regimen for the Selection and Evaluation Periods of the study. Minor adjustments to the dose of current AEDs are allowed only prior to Visit 1. Monotherapy subjects must not receive AED treatment, receive temporary AED treatment, or switch an AED prior to Visit 1
  • Subject weighs >=3.0 kg
  • Subject may have Vagal Nerve Stimulation (VNS) which has been implanted for at least 6 months prior to Visit 1; the settings must be stable for at least 2 months prior to Visit 1. Activated VNS must be counted as 1 of the 2 AEDs
  • Subject must have experienced at least 2 partial seizures, with or without secondary generalization during each 7-day period during the 2 weeks prior to Visit 1. This time period (the 2 weeks prior to Visit 1) will be referred to as the Retrospective Baseline Period. This seizure information (including type, frequency, and date) must have been recorded on a daily record card (DRC) in order to be acceptable
  • Subjects 1 month to <6 months of age must experience at least 2 partial seizures, during the 48 h video-EEG performed prior to Visit 3 (Week 0). These seizures do not need to be accompanied by a corresponding clinical event
  • Subjects 6 months to <4 years of age must experience at least 2 partial seizures, whether or not secondarily generalized, during the 48 h video-EEG performed prior to Visit 3 (Week 0). These seizures must be accompanied by a corresponding clinical event as noted on either video or as reported by investigator/subinvestigator
  • If epilepsy surgery has been performed prior to study entry, subjects must have a documented failed epilepsy surgery outcome at least 4 weeks prior to Visit 1
  • The use of intermittent benzodiazepines, phenobarbitals, and phenytoins is allowed as long as the frequency is not greater than 1 single administration per week for at least 2 weeks prior to Visit 1 and throughout study participation. If benzodiazepines are used more than once a week, they must be considered as 1 of the AEDs

Exclusion Criteria:

  • Subject has been taking any medication (other than their concomitant AEDs) that influences the central nervous system (CNS) for which they had not been on a stable regimen for at least 1 month prior to Visit 1
  • Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or LEV during the course of the study
  • Subject has received any investigational medication or device within 30 days prior to Visit 1
  • Subject has taken LEV prior to the study
  • Subjects using felbamate who have presented with clinically significant abnormalities and/or hepatic function during felbamate treatment, and subjects who are taking felbamate <1year from the date of Visit 1
  • History of status epilepticus requiring hospitalization during the 30 days prior to Visit 1, except for status epilepticus occurring during the first 10 days of life
  • Subject has a treatable seizure etiology
  • Subject is on a ketogenic diet (concomitantly or within 30 days prior to Visit 1)
  • Subject has epilepsy secondary to progressing cerebral diseases
  • Subject has a current diagnosis of Rasmussen's syndrome, Landau-Kleffner disease or Lennox-Gastaut syndrome
  • Clinically significant deviations from reference range values for renal function or any of the other laboratory parameters required for this study, as determined by the Investigator
  • Clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator)
  • Allergy to pyrrolidine derivatives or a history of multiple drug allergies
  • Subject is known to have a terminal illness
  • Subject has a disorder or condition that may interfere with the absorption, distribution, metabolism, or excretion of medications
  • Subject has a history of or presence of pseudoseizures
  • Subject has any medical condition that might interfere with the subject's study participation
  • Subject has ≥3x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340064


Contacts
Layout table for location contacts
Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
Layout table for location information
Japan
Ep0100 015 Recruiting
Fukuoka, Japan
Ep0100 003 Recruiting
Hamamatsu, Japan
Ep0100 020 Recruiting
Hyōgo, Japan
Ep0100 006 Recruiting
Izumi, Japan
Ep0100 002 Recruiting
Kodaira, Japan
Ep0100 007 Recruiting
Koshi, Japan
Ep0100 021 Recruiting
Kōfu, Japan
Ep0100 009 Recruiting
Nagakute, Japan
Ep0100 005 Recruiting
Niigata, Japan
Ep0100 014 Recruiting
Okayama, Japan
Ep0100 013 Recruiting
Osaka, Japan
Ep0100 018 Recruiting
Saitama, Japan
Ep0100 004 Recruiting
Sapporo, Japan
Ep0100 010 Recruiting
Sendai, Japan
Ep0100 019 Recruiting
Sendai, Japan
Ep0100 016 Recruiting
Shinjuku-Ku, Japan
Ep0100 001 Recruiting
Shizuoka, Japan
Ep0100 008 Recruiting
Suita, Japan
Ep0100 017 Recruiting
Tokyo, Japan
Ep0100 022 Recruiting
Toyoake, Japan
Ep0100 012 Recruiting
Ōbu, Japan
Ep0100 011 Recruiting
Ōmura, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 844 599 2273 (UCB)

Layout table for additonal information
Responsible Party: UCB Japan Co. Ltd.
ClinicalTrials.gov Identifier: NCT03340064     History of Changes
Other Study ID Numbers: EP0100
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Japan Co. Ltd. ):
Epilepsy
Partial Seizures
Levetiracetam
Monotherapy
Adjunctive Treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Levetiracetam
Anticonvulsants
Nootropic Agents