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    Summary
    EudraCT Number:2014-004174-42
    Sponsor's Protocol Code Number:A9451162
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-06
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004174-42
    A.3Full title of the trial
    An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Subjects With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Subjects With Partial Seizures
    A.4.1Sponsor's protocol code numberA9451162
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00603473
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Japan Inc.
    B.1.3.4CountryJapan
    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 supportPfizer Japan Inc.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    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 Yes
    D.2.1.1.1Trade name Neurontin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGABAPENTIN
    D.3.2Product code PD-087842
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Yes
    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 INNGABAPENTIN HYDROCHLORIDE
    D.3.9.1CAS number 60142-96-3
    D.3.9.2Current sponsor codeTablet
    D.3.9.3Other descriptive nameGABAPENTIN
    D.3.9.4EV Substance CodeSUB07857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGABAPENTIN HYDROCHLORIDE
    D.3.9.1CAS number 60142-96-3
    D.3.9.2Current sponsor codePD-087842
    D.3.9.3Other descriptive nameGABAPENTIN
    D.3.9.4EV Substance CodeSUB07857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy with partial seizures (including secondarily generalized seizures)
    E.1.1.1Medical condition in easily understood language
    Chronic disorder of brain function characterized by seizures
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in pediatric subjects with partial seizures (including secondarily generalized seizures) when other antiepileptics do not provide satisfactory effects.
    To confirm that the upper limit of the 95 percent (%) confidence interval of R Ratio (mean) of the gabapentin group in this study will be below R Ratio (least squares mean) of the placebo group in overseas study.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 3 -15 years old at acquisition of informed consent
    2. Sex: Male or female
    3. Subjects seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League against Epilepsy).
    4. Subjects who started being treated with antiepileptic drug at least 1 year ago, and who have not been able to achieve adequate seizure control with at least 2 different antiepileptic drugs despite having received each for at least 4 weeks.
    5. Subjects receiving one, two, or three antiepileptic drugs at screening. However benzodiazepines which are administrated every day or alternate day are counted as one antiepileptic drug.
    6. Subjects must have had a computed tomography (CT) scan or a Magnetic resonance imaging (MRI) within 2 years prior to screening.
    7. Females of childbearing potential have a negative urine pregnancy test at screening.
    8. Subjects and 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, be co-operative and reliable. They, or reliable observers, must be thought able to document the occurrence of seizures.
    9. Subjects and /or legal guardians must give written informed consent prior to the start of the study. The acquisition of informed consent is made by Subjects as much as possible.
    E.4Principal exclusion criteria
    1. Subjects with seizures related to drugs, or acute medical illness.
    2. Any subject with an Aspartate Aminotransferase (AST), Alanine transaminase (ALT), total bilirubin, Blood urea nitrogen (BUN) or creatinine above twice the upper limit of normal range within 6 months prior to screening (if data is available) and at screening.
    3. Any subject with a white blood cell counts below 3000/ millimeter(mm)^3 or neutrophil counts below 1500/mm^3 within 6 months prior to screening (if data is available) and at screening.
    4. Subjects who had taken other investigational drugs within the last 3 months prior to screening.
    5. Subjects with a history of any serious medical or psychiatric disorder within 6 months prior to screening.
    6. Subjects with a history of a structural Central Nervous system (CNS) lesion or an encephalopathy shown to be progressive.
    7. Subjects with a structural lesion in the CNS or an encephalopathy shown to be progressive by CT scan or MRI within 2 years prior to screening.
    8. Subjects who had had any Anti-epileptic drug (AED) withdrawn within 4 weeks prior to screening.
    9. Subjects taking any non-AED medication that could alter the effectiveness of the subject’s medication response, seizure frequency or characteristics.
    10. Any suject not reasonably expected to complete the trial.
    11. Subjects with any other condition in which the investigator judge the subject unsuitable for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Response Ratio of Gabapentin in Japanese Paediatric Subjects With Partial Seizures
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 Weeks
    E.5.2Secondary end point(s)
    -Responder Rate
    -Percent Change in Seizure Frequency (PCH)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 12 Weeks
    - 12 Weeks
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 89
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 67
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    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 No
    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
    3 - 15 years old at acquisition of informed consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 89
    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)
    NONE
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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