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    Clinical Trial Results:
    A multicenter, open-label, randomized, parallel-group, active-controlled study comparing the efficacy and safety of Levetiracetam to Carbamazepine used as monotherapy in subjects (≥16 years) newly or recently diagnosed as suffering from epilepsy and experiencing partial seizures

    Summary
    EudraCT number
    2015-004586-84
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    30 Sep 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Apr 2016
    First version publication date
    03 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N01364
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01954121
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Pharma SA
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 +49 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 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
    30 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate the noninferiority of the efficacy of Levetiracetam (LEV 1000 mg/day) versus Carbamazepine immediate-release (CBZ-IR 400 mg/day) used as monotherapy for at least 6 months. Efficacy will be measured as a primary variable by 6-month seizure freedom in adult subjects (≥16 years of age) who are newly or recently diagnosed with epilepsy and are experiencing Partial Onset Seizures (POS) with or without secondarily generalized seizures.
    Protection of trial subjects
    None, population from 16 year-old
    Background therapy
    Not applicable
    Evidence for comparator
    Active Comparator=carbamazepine. Rationale: golden standard in epilepsy.
    Actual start date of recruitment
    26 Sep 2013
    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
    China: 436
    Worldwide total number of subjects
    436
    EEA total number of subjects
    0
    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)
    28
    Adults (18-64 years)
    387
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study started to enroll subjects in China in September 2013.

    Pre-assignment
    Screening details
    Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Levetiracetam
    Arm description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    Keppra
    Investigational medicinal product code
    LEV
    Other name
    Levetiracetam
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg and 500 mg levetiracetam tablets

    Arm title
    Carbamazepine-IR
    Arm description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
    Arm type
    Active comparator

    Investigational medicinal product name
    Carbamazepine immediate-release
    Investigational medicinal product code
    CBZ-IR
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg carbamazepine immediate-release tablets

    Number of subjects in period 1
    Levetiracetam Carbamazepine-IR
    Started
    220
    216
    Completed
    93
    125
    Not completed
    127
    91
         Subject did not follow instructions
    -
    2
         Protocol deviation
    -
    2
         Non-compliant with study procedures
    1
    -
         Lack of efficacy
    94
    41
         SAE, non-fatal
    1
    4
         Pregnancy
    1
    1
         AE, serious fatal
    1
    -
         Non-compliant patient
    1
    1
         AE, non-serious non-fatal
    5
    22
         Consent withdrawn by subject
    18
    12
         Lost to follow-up
    5
    6

    Baseline characteristics

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    Subject analysis sets

    Subject analysis set title
    Levetiracetam (Safety Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.

    Subject analysis set title
    Carbamazepine-IR (Safety Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.

    Subject analysis set title
    Levetiracetam (Per Protocol Set)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.

    Subject analysis set title
    Carbamazepine-IR (Per Protocol Set)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.

    Subject analysis sets values
    Levetiracetam (Safety Set) Carbamazepine-IR (Safety Set) Levetiracetam (Per Protocol Set) Carbamazepine-IR (Per Protocol Set)
    Number of subjects
    218
    215
    186
    171
    Age Categorical
    Units: Subjects
        <=18 years
    20
    22
        Adults (18-64 years)
    184
    186
        >=65 years
    14
    7
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    37.8 ± 16.2
    33.3 ± 14.3
    33.3 ± 14.3
    33.3 ± 14.3
    Gender Categorical
    Units: Subjects
        Male
    112
    121
        Female
    106
    94

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.

    Reporting group title
    Carbamazepine-IR
    Reporting group description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.

    Subject analysis set title
    Levetiracetam (Safety Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.

    Subject analysis set title
    Carbamazepine-IR (Safety Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.

    Subject analysis set title
    Levetiracetam (Per Protocol Set)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.

    Subject analysis set title
    Carbamazepine-IR (Per Protocol Set)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.

    Primary: Proportion of subjects remaining seizure free during the 6-months Evaluation Period

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    End point title
    Proportion of subjects remaining seizure free during the 6-months Evaluation Period
    End point description
    End point type
    Primary
    End point timeframe
    6-months Evaluation Period (From Week 4 to Week 30)
    End point values
    Levetiracetam (Per Protocol Set) Carbamazepine-IR (Per Protocol Set)
    Number of subjects analysed
    186
    171
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    47.3
    68.4
    Statistical analysis title
    Stasticial Analysis 1
    Statistical analysis description
    The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and >2 seizures) as covariates.
    Comparison groups
    Levetiracetam (Per Protocol Set) v Carbamazepine-IR (Per Protocol Set)
    Number of subjects included in analysis
    357
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    adjusted difference in proportions
    Point estimate
    -22.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -33.1
         upper limit
    -12.6
    Notes
    [1] - The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.

    Secondary: Proportion of subjects retained in the study for the duration of the period covering the Up Titration Period, Stabilization Period, and Evaluation Period

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    End point title
    Proportion of subjects retained in the study for the duration of the period covering the Up Titration Period, Stabilization Period, and Evaluation Period
    End point description
    End point type
    Secondary
    End point timeframe
    From Week 1 to Week 30
    End point values
    Levetiracetam (Per Protocol Set) Carbamazepine-IR (Per Protocol Set)
    Number of subjects analysed
    186
    171
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    48.4
    70.2
    No statistical analyses for this end point

    Secondary: Time to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period

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    End point title
    Time to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period
    End point description
    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
    End point type
    Secondary
    End point timeframe
    From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
    End point values
    Levetiracetam (Per Protocol Set) Carbamazepine-IR (Per Protocol Set)
    Number of subjects analysed
    186
    171
    Units: number
    number (not applicable)
        Number of qualifying events
    88
    45
    No statistical analyses for this end point

    Secondary: Time to first seizure during the Evaluation Period

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    End point title
    Time to first seizure during the Evaluation Period
    End point description
    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
    End point type
    Secondary
    End point timeframe
    From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
    End point values
    Levetiracetam (Per Protocol Set) Carbamazepine-IR (Per Protocol Set)
    Number of subjects analysed
    186
    171
    Units: number
    number (not applicable)
        Number of qualifying events
    87
    39
    No statistical analyses for this end point

    Secondary: Time to first seizure during the period covering the Up Titration Period, Stabilization Period, and Evaluation Period from the first dose of study drug

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    End point title
    Time to first seizure during the period covering the Up Titration Period, Stabilization Period, and Evaluation Period from the first dose of study drug
    End point description
    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
    End point type
    Secondary
    End point timeframe
    From Randomization (Week 1) up to Evaluation Visit (Week 30)
    End point values
    Levetiracetam (Per Protocol Set) Carbamazepine-IR (Per Protocol Set)
    Number of subjects analysed
    186
    171
    Units: number
    number (not applicable)
        Number of qualifying events
    97
    57
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35).
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Carbamazepine-IR (Safety Set)
    Reporting group description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.

    Reporting group title
    Levetiracetam (Safety Set)
    Reporting group description
    During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.

    Serious adverse events
    Carbamazepine-IR (Safety Set) Levetiracetam (Safety Set)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 215 (5.12%)
    9 / 218 (4.13%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epidural haemorrhage
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    2 / 215 (0.93%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenic purpura
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Status epilepticus
         subjects affected / exposed
    1 / 215 (0.47%)
    2 / 218 (0.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 215 (0.47%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Seizure
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menopausal symptoms
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 215 (0.00%)
    1 / 218 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    1 / 215 (0.47%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Carbamazepine-IR (Safety Set) Levetiracetam (Safety Set)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 215 (43.26%)
    92 / 218 (42.20%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    11 / 215 (5.12%)
    6 / 218 (2.75%)
         occurrences all number
    11
    6
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    11 / 215 (5.12%)
    2 / 218 (0.92%)
         occurrences all number
    11
    2
    White blood cell count decreased
         subjects affected / exposed
    11 / 215 (5.12%)
    1 / 218 (0.46%)
         occurrences all number
    14
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    18 / 215 (8.37%)
    33 / 218 (15.14%)
         occurrences all number
    29
    48
    Somnolence
         subjects affected / exposed
    7 / 215 (3.26%)
    20 / 218 (9.17%)
         occurrences all number
    8
    25
    Headache
         subjects affected / exposed
    16 / 215 (7.44%)
    19 / 218 (8.72%)
         occurrences all number
    47
    33
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    32 / 215 (14.88%)
    40 / 218 (18.35%)
         occurrences all number
    42
    48
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 215 (7.44%)
    12 / 218 (5.50%)
         occurrences all number
    18
    16
    Urinary tract infection
         subjects affected / exposed
    5 / 215 (2.33%)
    11 / 218 (5.05%)
         occurrences all number
    5
    12

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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