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    Summary
    EudraCT Number:2010-020764-38
    Sponsor's Protocol Code Number:A8241012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-020764-38
    A.3Full title of the trial
    PHASE 2, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, 4-WEEK INPATIENT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO FIXED DOSES OF PF-02545920 COMPARED TO PLACEBO IN THE TREATMENT OF ACUTE EXACERBATION OF SCHIZOPHRENIA USING RISPERIDONE AS AN ACTIVE CONTROL
    A.4.1Sponsor's protocol code numberA8241012
    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, US
    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 namePF-02545920
    D.3.2Product code PF-02545920
    D.3.4Pharmaceutical form Tablet
    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 INNPF-02545920
    D.3.9.3Other descriptive name2-[[4-[1-Methyl-4-(4-pyridinyl)-1H-pyrazol-3-yl]phenoxy]methyl]quinoline butanedioic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Risperdal®
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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*
    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.3.9.1CAS number 106266-06-2
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Risperdal®
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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*
    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.3.9.1CAS number 106266-06-2
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10009134
    E.1.2Term Chronic schizophrenia
    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 of PF-02545920 in the treatment of acute exacerbation of schizophrenia during a 4-week double-blind treatment period using the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms from baseline compared to placebo.
    •To evaluate the safety and tolerability of two fixed dose regimens of PF-02545920 in the treatment of acute exacerbation of schizophrenia.
    •To evaluate the incidence rate of dystonia associated with two doses of PF-02545920 compared to placebo in the treatment of acute schizophrenia.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of PF-02545920 in the treatment of acute exacerbation of schizophrenia using the:
    •Clinical Global Impression of Improvement (CGI-I) and Clinical Global Impression of Severity (CGI-S);
    •PANSS Subscales: Positive, Negative, General;
    •PANSS derived Marder factor scores1 (positive, negative, disorganized thought, hostility/excitement, anxiety/depression);
    •PANSS derived Brief Psychiatric Rating Scale (BPRS) core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content);
    •Global Assessment of Function (GAF);
    •Treatment Satisfaction Questionnaire for Medication (TSQM).
    Other secondary objectives:
    •Collection of de-identified molecular profiling blood samples to support qualification of exploratory biomarkers and pharmacogenomic endpoints for use in future studies of PF-02545920 and other novel neuroscience therapeutic compounds.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Males or females aged 18-65 years of age (inclusive) are eligible.
    2. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    4. Body Mass Index (BMI) of approximately 18 to 40 kg/m2; and a total body weight
    >50 kg (110 lbs).
    5. Subjects with a diagnosis of schizophrenia must meet the following eligibility criteria in order to be considered for participation in the study. All psychiatric diagnoses specified in the inclusion/exclusion criteria are according to the DSM-IV TR criteria. The subjects are to be assessed by a qualified psychiatrist. The Mini International Neuropsychiatric Interview (M.I.N.I.) will be used to confirm diagnosis and exclude comorbid diagnoses:
    • Subjects must have a total BPRS score of ≥45 at the screen visit.
    • Subjects must have a score of ≥4 (moderate) on at least 2 items of the 4 BPRS core psychosis items (ie, #4 conceptual disorganization, #11 hallucinatory behavior, #12 suspiciousness, #15 unusual thought content) at screening and baseline.
    • Subjects must have a total score of at least 12 on the combination of the 4 BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) at screening and baseline.
    • Subjects must have a Clinical Global Impression of Severity (CGI-S) scale score of
    ≥4 (moderately ill) at the screen and baseline visit.
    6. Subjects must have a known change in their level of functioning associated with their current acute exacerbation of schizophrenia (eg, ER admission, change in level of supervision, worsening of symptoms) as noted/documented by the treating psychiatrist, family member or caregiver, or other clinical information source.
    7. The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the screen date. Narrative information must be recorded in the screening worksheets documenting the acuteness of current episode, history of exacerbations, and levels of response to past treatments.
    8. If subjects are hospitalized for acute exacerbation of schizophrenia at the time of screening, the duration of the current hospitalization must be less than 2 weeks prior to the screen date.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study (the list of exclusion criteria is abridged - a full list of exclusion criteria can be found within the protocol):
    1. Subjects who have a greater than a 25% decrease in the BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) total score between screening and baseline.
    2. Female subjects who are pregnant or breastfeeding: Female subjects of childbearing potential may be included in the study but must be sexually abstinent or must agree to practice established effective contraception from the screening evaluation until 30 days following the last dose of the study drug. Investigators should specifically question female subjects regarding potential unprotected sexual activity in the 14 days prior to screening to assess risk for pregnancy.
    3. Subjects with evidence or history of clinically significant hematological, renal, endocrine (excluding adequately controlled hypothyroidism or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), gastrointestinal (including conditions that can affect drug absorption, eg, gastrectomy), oncological, dermatologic, immunologic disease, as determined by the investigator. Controlled Type 2 diabetes (glucose <180 mg/100 mL at screening with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study.
    4. Subject with evidence or history of significant hepatic disorder, including acute or chronic hepatitis B and acute hepatitis C, with liver function test results higher than the normal limits. Subjects with positive hepatitis C antibody and normal liver functions tests can be included in the study.
    5. Subjects who are known to have AIDS or to be HIV positive.
    6. Subjects with evidence or history of clinically significant cardiovascular disease, including uncontrolled hypertension (sitting or supine diastolic pressure >95 mm Hg and/or sitting or supine systolic pressure >170 mm Hg with or without treatment), bypass surgery, history of myocardial infarction or ischemic heart disease, uncompensated heart failure or recent acute myocardial infarction. Controlled essential hypertension and non clinically significant sinus bradycardia and sinus tachycardia will not be considered significant medical illnesses and would not exclude a subject from the study.
    7. Subjects with a 12-lead ECG with repeated demonstration of QTcF >450 msec at screening or at baseline (Day 1) based on the machine reading.
    8. Subjects with a WBC<3500/mm3 and ANC <2000/mm3, or WBC <3000/mm3 and an ANC <1500/mm3 in subjects with a documented history of benign ethnic neutropenia.
    9. Subjects with a history of myeloproliferative disorder or clozapine induced agranulocytosis or granulocytopenia.
    10. Subjects with screening laboratory test results that deviate from the upper or lower limits of the reference range, except for not clinically significant values, as determined by the investigator. AST or ALT must be ≤2 X upper limit of reference range, and total bilirubin must be within 1.5 X of the upper limit of reference range at screening.
    11. Subjects who have a positive urine drug screen which cannot be explained by prescribed medications.
    12. Subjects who are using prohibited medications (as described in Section 5.5 and Appendix 1 of the protocol) and who will not be able to discontinue these concomitant medications after the screening visit.
    13. Subjects with a current DSM-IV axis I diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
    14. Subjects who have taken an investigational drug within 90 days prior to baseline.
    15. Subjects who meet DSM-IV defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
    16. Subjects who have attempted suicide within 3 months prior to Screening.
    17. For subjects who answer “Yes” the C SSRS questions 4 or 5 or a SBQ-R total score ≥8, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.
    18. Subjects who have received clozapine in the 6 months prior to randomization.
    19. Subjects who have received depot antipsychotic medication in the 3 months prior to randomization.
    20. Subjects with a history of hypersensitivity to treatment with risperidone.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy:
    • PANSS Total change from baseline.
    Primary Safety:
    • Dystonia incidence rate.
    Pharmacokinetics:
    •Sparse PK sampling for population PK analysis.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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 Yes
    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 in all participating countries is defined as the Last Subject Last Visit (LSLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 260
    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)
    Please see section 8.1 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 Decision2010-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-04
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