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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-014269-25
    Sponsor's Protocol Code Number:A0081096
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-08
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-014269-25
    A.3Full title of the trial
    PROSPECTIVE RANDOMIZED 12-WEEK CONTROLLED STUDY OF VISUAL FIELD CHANGE IN SUBJECTS WITH PARTIAL SEIZURES RECEIVING PREGABALIN OR PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective Randomized 12-Week Controlled Study of Visual Field Change in Subjects with Partial Seizures Receiving Pregabalin or Placebo
    A.4.1Sponsor's protocol code numberA0081096
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00351611
    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 Inc
    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 supportPfizer Inc
    B.4.2CountryUnited States
    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 codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    B.5.5Fax number+1 303 7391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 148-553-50-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    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 148-553-50-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    EPILEPSY WITH PARTIAL SEIZURE
    E.1.1.1Medical condition in easily understood language
    EPILEPSY WITH PARTIAL SEIZURE
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial epilepsy
    E.1.2System Organ Class 100000004852
    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 visual fields in subjects with partial epilepsy receiving 12 weeks treatment of pregabalin compared to placebo.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives in this study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of epilepsy with partial seizures (as defined in the International League
    Against Epilepsy Classification of Seizures). Diagnosis must be established by
    subject’s medical history (eg, seizures), family history, and the results of
    electroencephalogram testing done within 2 years prior to baseline (if none available,
    must be taken during Screening). Results must be consistent with the diagnosis of
    focal-onset epilepsy;
    2. Seizures should not have occurred within 2 weeks of an acute neurological event
    (eg, a stroke);
    3. Be currently taking 1 to 3 antiepileptic drugs (AEDs). Vagus nerve stimulator (VNS) device also will be considered an AED. AED should be continued without alteration of current dose during the study. Benzodiazepines and barbiturates will not be allowed as -treatment regardless of indication;
    4. Have magnetic resonance imaging (MRI) or computed tomography (CT) scan with contrast of the head within 3 years prior to randomization (if none available, must be taken during Screening) that demonstrates no progressive structural abnormality and non-lesional epilepsy;
    5. Subjects who, in the opinion of the investigator, may benefit from treatment with
    pregabalin;
    6. Be 18 to 65 years old;
    7. Be male, or nonpregnant, nonlactating female who is postmenopausal, surgically
    sterilized, or premenopausal using a reliable method of contraception (including
    barrier or hormonal method) and have a confirmed negative urine pregnancy test prior to randomization;
    8. Have a 12-lead electrocardiogram prior to randomization without clinically
    significant abnormal findings;
    9. On both screening and baseline visual field exam, any eye has <20% false positives, <30% false negatives, <30% fixation loss;
    10. Difference in mean deviation between screening and baseline visual field exams must be ≤2 decibels (dB) of mean deviation (MD) on both eyes;
    11. Provide written informed consent signed by subject or legal guardian prior to entering the study;
    12. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    1. Known previous or current serious ophthalmologic disease(including uncorrected cataracts or history of cataract surgery < 8 days), serious eye trauma or intra ocular or ocular surgery other than refractive (ie, lasik, cataract) surgery, or ophthalmologic finding that could affect the visual field; 2. Amblyopia;
    3. Ptosis;
    4. Manifest nystagmus in primary gaze;
    5. On medications that could affect the visual field or pupil eg, chloroquine or miotics;
    6. Refractive error in either eye exceeding +/-5 D (sphere) or +/-2.5 D (cylinder);
    7. Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity
    worse than 20/25 in either eye;
    8. Intra ocular pressure (IOP) >22 mmHg in either eye at Screening;
    9. Have clinically significant abnormal findings on ophthalmologic examinations
    including external eye examination, visual acuity test, intraocular pressure,
    funduscopy and repeated visual field test (VFT). Repeat any test if there is a finding
    that is uncertain. For VFT – if one test is normal and another one abnormal a third
    test may be performed. Two of the three tests being normal is acceptable;
    10. Subjects with glaucoma or a history of glaucoma;
    11. Family history of inherited retinal or optic nerve disorders;
    12. Subject with a history of intolerability to pregabalin, or with a history of
    insufficient response (based on investigator’s clinical judgment) to pregabalin in the treatment of partial seizure, or subjects with current pregabalin treatment;
    13. Subjects who currently have poorly controlled epileptic seizures which could
    interfere with test procedures;
    14. Childbearing potential female who is unable to take adequate contraceptive
    precautions, has a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, plans to become pregnant in the next 3 months or is currently breastfeeding an infant;
    15. Creatinine clearance ≤60 mL/min (estimated from serum creatinine);
    16. Have a history or clinical evidence of cardiovascular, hematologic, hepatic, or renal disease (ALT, AST, bilirubin, urea, or creatinine values above twice the upper limit of normal [ULN] at Screening) or any physical conditions that, in the opinion of the investigator, would compromise participation in the study;
    17. With a mental condition rendering the subject unable to be cooperative with and
    complete study requirements;
    18. Have a significant psychiatric disorder, recurrent episodes of severe depression (any pharmacologic treatment or hospitalization for the illness within 1 year prior to
    Screening), or subjects with serious suicidal risk per criteria described in the section
    7.5.1 of the protocol. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant
    are acceptable;
    19. Has received any investigational drug during the previous 60 days prior to first dose;
    20. Hypersensitivity to pregabalin or gabapentin;
    21. Meets criteria for alcohol or drug abuse within the past year;
    22. 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 subject inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    •The proportion of subjects with a decrease in the threshold value from baseline to termination in five or more points (in either eye) at the p<.05 level repeated in the same five points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of subjects with a decrease in the threshold value from baseline to Week 12 for any five points (in either eye) at the p<.05 level repeated in the same five points on subsequent computerized automated perimetry testing (Humphrey 24 2 SITA standard).
    E.5.2Secondary end point(s)
    •Change in mean deviation score from baseline to Week 12 from the Humphrey threshold test
    •Change in visual acuity from Baseline to Week 12 expressed by number identified in ETDRS visual acuity assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in mean deviation score from baseline to Week 12 from the Humphrey threshold test;
    Change in visual acuity from Baseline to Week 12 expressed by number identified in ETDRS visual acuity assessment.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Czech Republic
    Hungary
    India
    Korea, Republic of
    Mexico
    Poland
    Thailand
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    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 months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 284
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 284
    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)
    Poland and Hungary: the subject could receive pregabalin for 6 months after the study period at no charge. As pregabalin is on the market in these countries, we will reimburse this treatment to the patients when the investigator and the patient request it.

    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 Decision2009-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
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