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    Clinical Trial Results:
    An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

    Summary
    EudraCT number
    2007-000899-17
    Trial protocol
    PL  
    Global end of trial date
    31 Mar 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    24 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N01281
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00419393
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Pharma S.A.
    Sponsor organisation address
    Chemin du Foriest, Braine-l’Alleud, Belgium, B - 1420
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jun 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To provide continued treatment of Keppra XR for subjects who participated in the pivotal conversion to monotherapy study (N01280) and to assess the long-term safety of Keppra XR in patients with partial onset seizures.
    Protection of trial subjects
    • Dose adjustment due to tolerability • The ongoing monitoring of safety data was performed to detect as early as possible any safety concern related to the investigational product.
    Background therapy
    Not Applicable
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    28 Feb 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 26
    Country: Number of subjects enrolled
    Poland: 59
    Country: Number of subjects enrolled
    Russian Federation: 56
    Country: Number of subjects enrolled
    Mexico: 49
    Worldwide total number of subjects
    190
    EEA total number of subjects
    59
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    27
    Adults (18-64 years)
    160
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study recruitment began in February 2008 in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.

    Pre-assignment
    Screening details
    Participant Flow refers to the Intent-to-treat (ITT) Population consisting of all subjects who completed an informed consent.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Keppra XR (Levetiracetam XR)
    Arm description
    1000 – 3000 mg/day Keppra XR (LevetiracetamXR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
    Arm type
    Experimental

    Investigational medicinal product name
    Keppra XR
    Investigational medicinal product code
    ucb L059
    Other name
    Keppra XR
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study.

    Number of subjects in period 1
    Keppra XR (Levetiracetam XR)
    Started
    190
    Completed
    166
    Not completed
    24
         Other: Investigator decision
             1
         Protocol deviation
             5
         Other: Other health problems
             1
         Other: Site closure
             1
         SAE, non-fatal
             3
         Other: Subject had temporal lobectomy
             1
         AE, serious fatal
             1
         AE, non-serious non-fatal
             1
         Other: Sponsor request
             3
         Consent withdrawn by subject
             7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Keppra XR (Levetiracetam XR)
    Reporting group description
    1000 – 3000 mg/day Keppra XR (LevetiracetamXR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

    Reporting group values
    Keppra XR (Levetiracetam XR) Total
    Number of subjects
    190 190
    Age Categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    27 27
        Adults (18-64 years)
    160 160
        From 65-84 years
    3 3
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    33.44 ± 14.46 -
    Gender Categorical
    Units: Subjects
        Female
    111 111
        Male
    79 79
    Region of Enrollment
    Units: Subjects
        United States
    26 26
        Mexico
    49 49
        Poland
    59 59
        Russian Federation
    56 56

    End points

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    End points reporting groups
    Reporting group title
    Keppra XR (Levetiracetam XR)
    Reporting group description
    1000 – 3000 mg/day Keppra XR (LevetiracetamXR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

    Subject analysis set title
    Efficacy Population Keppra XR
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The Efficacy Analysis Population (EFF) was defined as all subjects in the Safety Population who have at least one efficacy measurement reported (eg, at least one day of seizure diary data) in the N01281 study. All efficacy analyses were performed using the EFF population.

    Subject analysis set title
    Safety Set Keppra XR
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of study medication.

    Primary: Number of subjects who experienced at least 1 treatment emergent adverse event during the actual Treatment Period (6 months-2 years)

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    End point title
    Number of subjects who experienced at least 1 treatment emergent adverse event during the actual Treatment Period (6 months-2 years) [1]
    End point description
    An adverse event 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.
    End point type
    Primary
    End point timeframe
    Duration of the Treatment Period (6 months-2 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Safety Set Keppra XR
    Number of subjects analysed
    189
    Units: number of subjects
        Number of subjects
    126
    No statistical analyses for this end point

    Primary: Number of subjects who experienced at least 1 serious treatment emergent adverse event during the actual Treatment Period (6 months-2 years)

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    End point title
    Number of subjects who experienced at least 1 serious treatment emergent adverse event during the actual Treatment Period (6 months-2 years) [2]
    End point description
    A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
    End point type
    Primary
    End point timeframe
    Duration of the Treatment Period (6 months-2 years)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Safety Set Keppra XR
    Number of subjects analysed
    189
    Units: number of subjects
        Number of subjects
    22
    No statistical analyses for this end point

    Primary: Number of subjects prematurely discontinuing due to a treatment-emergent adverse event during the actual Treatment Period

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    End point title
    Number of subjects prematurely discontinuing due to a treatment-emergent adverse event during the actual Treatment Period [3]
    End point description
    An adverse event 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.
    End point type
    Primary
    End point timeframe
    Duration of the Treatment Period (6 months-2 years)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Safety Set Keppra XR
    Number of subjects analysed
    189
    Units: number of subjects
        Number of subjects
    5
    No statistical analyses for this end point

    Secondary: Percentage of subjects remaining on Keppra XR Monotherapy from study entry through 6 months

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    End point title
    Percentage of subjects remaining on Keppra XR Monotherapy from study entry through 6 months
    End point description
    Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
    End point type
    Secondary
    End point timeframe
    Study entry through 6 months
    End point values
    Safety Set Keppra XR
    Number of subjects analysed
    139
    Units: percentage of subjects
        Percentage of subjects
    77
    No statistical analyses for this end point

    Secondary: Percentage of subjects remaining on Keppra XR monotherapy from study entry through 12 months

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    End point title
    Percentage of subjects remaining on Keppra XR monotherapy from study entry through 12 months
    End point description
    Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.
    End point type
    Secondary
    End point timeframe
    Study entry through 12 months
    End point values
    Efficacy Population Keppra XR
    Number of subjects analysed
    49
    Units: percentage of subjects
    number (not applicable)
        Percentage of subjects
    65.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to two years
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Keppra XR (Levetiracetam XR)
    Reporting group description
    1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

    Serious adverse events
    Keppra XR (Levetiracetam XR)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 189 (11.64%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy with contraceptive device
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Chest pain
         subjects affected / exposed
    2 / 189 (1.06%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Anticonvulsant toxicity
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar puncture headache
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    4 / 189 (2.12%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postictal paralysis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic fibrosis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Toxic skin eruption
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Periostitis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Keppra XR (Levetiracetam XR)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 189 (30.16%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 189 (5.29%)
         occurrences all number
    19
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    15 / 189 (7.94%)
         occurrences all number
    18
    Headache
         subjects affected / exposed
    26 / 189 (13.76%)
         occurrences all number
    57
    Dizziness
         subjects affected / exposed
    10 / 189 (5.29%)
         occurrences all number
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 189 (7.94%)
         occurrences all number
    19
    Influenza
         subjects affected / exposed
    14 / 189 (7.41%)
         occurrences all number
    27

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Mar 2007
    Protocol Amendment 1 provided for administrative changes and added blood urea nitrogen (BUN) to the clinical chemistry assessments to be performed. This amendment was implemented before any subjects were enrolled in the study.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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