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    Summary
    EudraCT Number:2015-000606-20
    Sponsor's Protocol Code Number:A1281132
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-03
    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 number2015-000606-20
    A.3Full title of the trial
    Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
    A.4.1Sponsor's protocol code numberA1281132
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00257166
    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 code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    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 Geodon/Zeldox
    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 nameZiprasidone HCl
    D.3.2Product code CP-88059-1
    D.3.4Pharmaceutical form Capsule
    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 INNZIPRASIDONE
    D.3.9.1CAS number 146939-27-7
    D.3.9.4EV Substance CodeSUB00168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    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
    Bipolar Disorder
    E.1.1.1Medical condition in easily understood language
    Mental condition marked by alternating periods of elation and depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 establish efficacy of oral ziprasidone (60-80 milligram [mg] Twice a day [BID]) compared with placebo in the treatment of children and adolescents with Bipolar I Disorder - Single Manic Episode, Bipolar I Disorder – Most Recent Episode Manic; or Bipolar I Disorder – Most Recent Episode Mixed; as measured by the change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.
    To evaluate the safety and tolerability of oral ziprasidone (60-80 mg BID) over 4 weeks in the treatment of children and adolescents with Bipolar I Disorder (manic or mixed)
    E.2.2Secondary objectives of the trial
    To evaluate efficacy of oral ziprasidone (60-80 mg BID) as compared with placebo in the treatment of children and adolescents with Bipolar I Disorder (manic or mixed), as measured by Change from baseline in Clinical Global Impression of Severity (CGI-S) score.
    To characterize the population pharmacokinetics of oral ziprasidone (60-80 mg BID) in children and adolescents with Bipolar I Disorder (manic or mixed), including Pharmacokinetic/Pharmacodynamic (PK/PD) analysis for QTc measurements.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent.
    2. The subject (male or female) must be between 10-17 (inclusive) years of age at screening.
    3. The subject must have a primary diagnosis of Bipolar I Disorder - Single Manic Episode, Bipolar I Disorder – Most Recent Episode Manic, or Bipolar I Disorder – Most Recent Episode Mixed, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria and confirmed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS).
    4. The current symptoms must have been present for at least 7 days prior to Screening.
    5. At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score greater than or equal to () 17
    6. In the investigator’s opinion, the subject must be likely to benefit from therapy with an atypical antipsychotic drug.
    7. The subject must have a Body Mass Index (BMI) within the 5th-95th percentile as determined from BMI charts from the Centers for Disease Control.
    8. The subject is willing and able to discontinue any medications that are prohibited in this study (see Concomitant Medications table, Section 5.5). Any such medications must be discontinued at least 4 half-lives (or 10 ten days, whichever is less) prior to the administration of double-blinded study medication.
    9. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria:
    Are instructed and agree to avoid pregnancy during the study.
    Have a negative urine pregnancy test (β-HCG) at screening and baseline.
    Use one of the following birth control methods: a) an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g. Ortho-Evra), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; b) a barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study, c) abstinence for at least 3 months before the start of the study and intention to abstain from sexual activity during the study period.
    E.4Principal exclusion criteria
    1. Subjects who are clinically stable on treatment regimens that are being well tolerated.
    2. Subjects with substance-induced psychotic disorder or whose behavioral disturbance is thought to be due to substance abuse.
    3. Subjects with DSM-IV defined psychoactive substance or alcohol abuse/dependence (does not apply to nicotine or caffeine) within the preceding 1 month.
    4. Subjects with a rating of 7 on the single Suicidal Ideation item (item #13) from the Child Depression Rating Scale- Revised (CDRS-R), or who are otherwise judged by the investigator as being at imminent risk of suicide.
    5. Subjects who are judged by the investigator as being at imminent risk of homicide
    6. Subjects with significant mental retardation (i.e. Intelligence quotient [IQ] less than [<] 70) that would interfere with study conduct or with the interpretation of the study assessments.
    7. Subjects with autism or pervasive developmental disorder.
    8. Subjects with any serious, unstable illness including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic (including controlled or uncontrolled Type I diabetes), immunologic, hematologic, dermatological, oncological, or neurological disease (including any history of seizure or epilepsy).
    9. Subjects with a history of syncopal episodes (sudden loss of consciousness with loss of postural tone and not preceded by a pre-syncopal phase) or unexplained loss of consciousness.
    10. Subjects with any medical condition or dietary habit that has a significant potential to alter the absorption of the study drug; or subjects taking any medication that may alter drug absorption. (eg anorexia nervosa, bulimia, chronic use of laxatives).
    11. Subjects with uncorrected hypothyroidism or hyperthyroidism or whose thyroid function and medication regimen have been stable less than 1 month.
    12. Subjects with any screening laboratory value that deviates significantly from the upper or lower limits of the normal reference range. Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) must be within 2 X and total bilirubin must be within 1.5 X times of the upper limits of the reference range.
    13. Subjects with a history of chronic hepatitis, known serologic evidence of acute hepatitis or chronic hepatitis (positive HbsAg), or subjects with known hepatitis C antibodies and elevated Liver function tests (LFTs).
    14. Subjects known to be human immunodeficiency virus (HIV) positive.
    15. Subjects with clinically significant hypokalemia or hypomagnesemia not corrected and stabilized by the addition of dietary supplements or some other corrective measure prior to Baseline.
    16. Subjects with a history of significant cardiovascular disease or significant concurrent cardiovascular disease, including uncontrolled hypertension (sitting diastolic pressure greater than[>]90 millimeters mercury (mm Hg) and/or sitting systolic pressure > 140 mm Hg with or without treatment), hypotension, congestive heart failure, or congenital heart disease.
    17. Subjects with a history of cardiac arrhythmias, conduction abnormalities or known personal history of QT prolongation (including congenital long QT syndrome).
    18. Subjects with a known genetic risk for prolonged QT syndrome
    19. Subjects with a clinically significant electrocardiogram (ECG) abnormality at Screening or Baseline
    20. Subjects with persistent QTc (Fridericia) >= 460 msec at Screening or Baseline.
    21. Subjects taking any medications not allowed by the Concomitant Medication Table (Section 5.5). Medications should be avoided that may mask or exacerbate adverse effects, or have psychotropic properties which would exacerbate symptoms (eg, sympathomimetics) or obscure study drug effect (eg, antihistamines).
    22. Subjects who have received clozapine within 12 weeks, a depot antipsychotic within 4 weeks or a monoamine oxidase inhibitor within 2 weeks prior to Baseline.
    23. Subjects known by medical history or hospitalization records to have used phencyclidine within the 30 days prior to Screening.
    24. Subjects requiring treatment with drugs which have been consistently observed to prolong the QT interval.
    25. Subjects who received an investigational drug within 4 weeks of Baseline.
    26. Subjects who received ziprasidone in a previous clinical trial.
    27. Subjects known to be allergic to ziprasidone.
    28. Subjects with history of antipsychotic-induced extrapyramidal symptom (EPS) that does not respond to antiparkinsonian medication.
    29. Subjects with prior episode of neuroleptic malignant syndrome or prior hypersensitivity to antipsychotic agents.
    30. Subjects with a history of non-responsiveness to ziprasidone after an adequate treatment period at a dose between 120-160 mg daily.
    E.5 End points
    E.5.1Primary end point(s)
    Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 4
    E.5.2Secondary end point(s)
    -Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3 (Baseline, Week 1, 2, 3)
    -Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4
    -Clinical Global Impression - Improvement (CGI-I) Score at Week 1, 2, 3, 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 1, 2, 3
    Week 1, 2, 3, 4
    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 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 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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    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 months6
    E.8.9.2In all countries concerned by the trial days14
    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: 236
    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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 186
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    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
    Subjects less than 18 years of age
    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 237
    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: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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