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    Summary
    EudraCT Number:2010-020730-26
    Sponsor's Protocol Code Number:A0081074
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2010-020730-26
    A.3Full title of the trial
    A PLACEBO-CONTROLLED, ESCALATING DOSE, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES
    A.4.1Sponsor's protocol code numberA0081074
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc.235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePregabalin
    D.3.2Product code PD-144723
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codePD-0144723
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PARTIAL ONSET SEIZURES
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10034089
    E.1.2Term Partial seizures NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the escalating single- and multiple-dose safety and tolerability of pregabalin, in comparison to placebo, in pediatric patients 1 month through 16 years of age with partial onset seizures.
    • To evaluate the single-dose and steady-state pharmacokinetics of pregabalin in pediatric patients 1 month through 16 years of age with partial onset seizures.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Male and female epilepsy patients, age 1 month (44 weeks gestational age) to 16 years inclusive, with a minimum body weight of 3.5 kg.
    2. Seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Classification of Seizures. Partial onset seizures must be diagnosed in either of two ways:
    a. Clinical observation of partial seizures with focal semiology confirmed by and consistent with the localization of either:
    • Focal epileptiform abnormality on EEG within the last 2 years, or
    • Focal abnormality on imaging; or
    b. Seizure recorded by EEG monitoring which fulfills the ILAE criteria for EEG seizure type within the last 2 years.
    3.Must have a partial seizure frequency of at least 1 seizure per 28 day month prior to enrollment.
    4. Currently receiving a stable dosage of 1 to 3 antiepileptic drugs (stable within 7 days of screening), with blood levels within typically accepted therapeutic range. Benzodiazepine medication used at a stable dosage and frequency for rescue treatment will be considered one of the concurrent antiepileptic treatments.
    5. A head CT scan with contrast, or MRI of the brain (at any time prior to study participation), demonstrating no abnormality that is likely to be progressive, and no clinical evidence of a progressive abnormality.
    6. A 12 lead ECG at screening without significant abnormal findings.
    7. Subjects and parents/legal guardians must be thought to be compliant and able to follow the investigator’s instructions. They must be able to visit the clinic on schedule and be both cooperative and reliable.
    8. Parents/legal guardians must give written informed consent prior to the start of the study. Consent should be obtained from both (if available) of the child’s legal representatives (parents or guardians). Whenever the minor child is able to give assent, the minor’s assent must be obtained.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 6 months of screening.
    2. Primary (eg, absence epilepsy) or secondary (eg, Lennox-Gastaut syndrome, infantile spasms, myoclonic or atonic epilepsies) generalized epilepsy.
    3. Seizures related to drugs, alcohol, or acute medical illness.
    4. Any change in AED regimen during the last 7 days prior to screening.
    5. Progressive structural CNS lesion or a progressive encephalopathy. Progressive inborn errors of metabolism.
    6. Known or suspected chronic hematologic, hepatic or renal disease (AST and ALT above 3 times the upper limit of normal; or bilirubin, BUN, or creatinine above 2 times the upper limit of normal within the previous 6 months for infants, children and adolescents aged 6 months or more, or at any postnatal period for infants younger than 6 months).
    7. Known or suspected white blood cell counts below 3000/mm3; absolute neutrophil counts of less than 1500/mm3, or platelet counts of less than 100x103/mm3.
    8. Estimated creatinine clearance (ClCR) <80 mL/min/1.73m2. The Cockcroft Gault equation normalized for body surface area will be used for estimating creatinine clearance for ages 12-16 years. Creatinine clearance (in units of ml/min/1.73m2) will be estimated for the younger children using the following equations:
    ClCR = 0.45×length (cm)/serum creatinine (mg/dL), for infants 1 to <12 months old;
    ClCR = 0.55×length (cm)/serum creatinine (mg/dL), for children 1 to <12 years old.
    9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
    10. Pregnant or nursing females (females age 10 or greater, or who are menarchal must have a negative pregnancy test); menarchal females of childbearing potential who are unwilling or unable to use an acceptable method of contraception, as outlined in the protocol, from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures.
    11.Any condition possibly affecting drug absorption (eg, gastrectomy).
    12.Taking any non-antiepileptic (non-AED) medication that could alter the effectiveness of the patient’s medication, response, seizure frequency or characteristics. The use of gabapentin, felbamate, vigabatrin, or agents with central nervous system activity within 1 week of screening, and throughout the study, is prohibited.
    13. Taking or have taken any other investigational drug within the last 30 days prior to screening.
    14. A positive urine drug screen for non-therapeutic drugs (subjects testing positive will not be randomized).
    15. Unwilling or unable to comply with the Lifestyle Guidelines.
    16. Use of tobacco- or nicotine-containing products.
    17. Previous use of pregabalin.
    18. History of sensitivity to heparin or heparin-induced thrombocytopenia.
    19. Not reasonably expected to complete the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints will be evaluated throughout the 8 day study period. Data collected on the first 7 days of the study period will be double-blind placebo-controlled. Data collected on Day 8 will be double-blind as to whether subjects are under single-dose conditions (those who received placebo on Days 1 7) or under multiple dose conditions (those who received pregabalin on Days 1 7). Blood samples for pharmacokinetics will be collected beginning on Day 8.
    The safety and tolerability data for each age/dose group will be unblinded when data collection is completed for that age/dose group. The evaluation of safety and tolerability of that dose level in that age group will be based on the review of this unblinded data.
    3.3.1. Safety Endpoints
    Data on the following endpoints will be collected throughout the 8-day study period:
    •Frequency and severity of adverse events
    •Physical and neurologic exams
    •Vital signs
    •ECGs
    •Laboratory tests: hematology, chemistry (fasting), urinalysis
    •Seizure frequency
    3.3.2. Pharmacokinetic Endpoints
    Serial blood samples and urine collected beginning on Day 8 will be analyzed for pregabalin concentration. The concentration data will be used to assess the following pharmacokinetic parameters:
    •AUC(0-24)
    •Cmax
    •Tmax
    •t1/2
    •Fraction of dose excreted unchanged in urine.
    •CL/F (apparent total clearance)
    •CLr (renal clearance)
    •Vd/F (apparent volume of distribution)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pediatric PK and Safety/Toleration study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dose-escalation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial is defined as LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parents/legal guardians must give written informed consent prior to study start. Consent to be obtained from child’s legal representatives (parents or guardians). Whenever the minor child is able to give assent, the minor’s assent must be obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following participation in the A0081074 study, subjects have an option to enroll in a 1 year open-label extension study (protocol A0081075), as described in section 3.1 of the protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-13
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