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    Summary
    EudraCT Number:2008-002675-27
    Sponsor's Protocol Code Number:31-07-246
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-30
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2008-002675-27
    A.3Full title of the trial
    A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia
    “ASPIRE US” (Aripiprazole Intramuscular Depot Program in Schizophrenia)
    A.3.2Name or abbreviated title of the trial where available
    ASPIRE US
    A.4.1Sponsor's protocol code number31-07-246
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 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 namearipiprazole 400 mg vial IM depot
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntramuscular 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 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.2Term 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 aripiprazole IM depot compared with placebo, as measured by time to exacerbation of psychotic symptoms/impending relapse, in schizophrenic patients who have maintained stability on aripiprazole IM depot for at least 12 weeks.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of aripiprazole IM depot as maintenance therapy in patients with schizophrenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening
    1. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC), prior to the initiation of any protocol-required procedures.
    2. Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
    3. Subjects with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least 3 years prior to screening.*
    4. Subjects who, in the investigator’s judgment, require chronic treatment with antipsychotic medication(s).
    5. Subjects who showed previous response to antipsychotic treatment (other than clozapine) in the past year, according to the investigator’s opinion.
    6. Subjects who are current treatment with oral or depot antipsychotics other than clozapine (a recent lapse in antipsychotic treatment [defined as >3 consecutive days without medication] will be considered as current treatment for the purpose of determining eligibility for this trial) and who, in the investigator’s judgment, require chronic treatment with an antipsychotic medication and would benefit from treatment with aripiprazole IM depot.
    7. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
    8. Inpatient or outpatient status prior to entry into Phase 3 (single-blind IM depo stabilization).
    9. Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.

    Inclusion Criteria Assessed Prior to Entry into Phase 1
    10. Adequate washout of prohibited concomitant medications, including 3 days prior to entry into Phase 1 for mood stabilizers and antidepressants (14 days for fluoxetine or Symbyax).
    11. Subject is receiving no more than one benzodiazepine beyond screening.*
    12. Inpatient or outpatient status.
    13. Subject is receiving antipsychotic(s) other than aripiprazole or clozapine and must be cross-titrated to aripiprazole monotherapy (study drug) over 4 to 6 weeks using an initial dose of 5 mg to achieve a recommended target aripiprazole monotherapy starting dose in Phase 2 of 10 or 15 mg.*

    Inclusion Criteria Assessed Prior to Entry into Phase 2
    14. Adequate washout of prohibited concomitant medications.*
    15. Subject is receiving oral aripiprazole as monotherapy (generic aripiprazole must be cross-titrated in Phase 1) for treatment of schizophrenia at a starting dose of 10 or 15 mg daily.*
    16. Inpatient/outpatient status.

    Inclusion Criteria Assessed Prior to Entry into Phase 3
    17. Subject is receiving oral aripiprazole as monotherapy (generic aripiprazole must be cross-titrated in Phase 1) for treatment of schizophrenia at a dose ranging from 10 to 30 mg daily.
    18. Outpatient status.
    19. Subject’s condition is stable as evidenced by meeting ALL of the following criteria for 4 consecutive weeks (2 consecutive bi-weekly visits), including the last visit prior to entering Phase 3:
    a) Outpatient status
    b) PANSS Total Score =<80
    c) Lack of specific psychotic symptoms as measured by a score of =<4 on the following PANSS items:
    • Conceptual disorganization
    • Suspiciousness
    • Hallucinatory behavior
    • Unusual thought content
    d) CGI-S =<4 (moderately ill)
    e) CGI-SS =<2 (mildly suicidal) on Part 1 and =<5 (minimally worsened) on Part 2
    20. Stability criteria are met on or before Week 12 of Phase 2.

    Inclusion Criteria Assessed Prior to Entry into Phase 4
    21. Subject is receiving single-blind aripiprazole IM depot and meets ALL of the criteria mentioned in the previous section, for 12 weeks (6 consecutive bi-weekly visits), including the final visit of Phase 3.*
    22. Stability criteria are met on or before Week 36 of Phase 3 at a visit where an IM depot injection is scheduled. *

    *See Protocol for explanatory details
    E.4Principal exclusion criteria
    Sex and Reproductive Status
    1. Sexually active males not practicing double-barrier birth control or who will not remain abstinent during the study and for 180 days following the last dose of study medication, or sexually active females of childbearing potential not practicing double-barrier birth control or who will not remain abstinent during the study and for 150 days following the last dose of study medication. If employing birth control, 2 precautions to be used*
    2. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug.

    Target Disease
    3. Subjects with a current DSM-IV-TR diagnosis other than schizophrenia*
    4. Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator’s opinion, that requires treatment with an antidepressant.
    5. Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history.
    6. Subjects with a history of failure to clozapine treatment or response to clozapine treatment only.

    Medical History and Concurrent Disease
    7. Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator’s judgment.
    8. Subjects who currently meet DSM-IV-TR criteria for substance dependence*
    9. Subjects with known hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days).
    10. Subjects having a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial*
    11. Subjects with epilepsy or a history of seizures, except for a single childhood febrile seizure, post traumatic, alcohol withdrawal, etc.

    Physical and Laboratory Test Findings
    12. Subjects with two positive drug screens for cocaine prior to Phase 2*
    13. The following laboratory test, vital sign, and ECG results are exclusionary:
    a) Platelets =<75,000/mm3
    b) Hemoglobin =<9 g/dL
    c) Neutrophils, absolute =<1000/mm3
    d) AST > 3x upper limit of normal
    e) ALT > 3x upper limit of normal
    f) Creatinine >=2 mg/dL
    g) Diastolic blood pressure > 105 mmHg
    h) QTc > 475 msec*

    Allergies and Adverse Drug Reactions
    14. Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
    15. Subjects with a history of hypersensitivity to antipsychotic agents.
    16. Subjects who are known to be allergic, intolerant, hypersensitive, or refractory to antipsychotic agents.
    17. Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

    Prohibited Therapies and/or Medications
    18. Subjects likely to require prohibited concomitant therapy during the trial.
    19. Subjects receiving CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers at screening or anticipated use of such agents during the trial*
    20. Subjects who received any investigational agent in a clinical trial within 30 days prior to screening or who were randomized into a clinical trial with aripiprazole IM depot at any time*

    Other Exclusion Criteria
    21. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this trial.
    22. Subjects who have been hospitalized, including hospitalization for psychosocial reasons, for more than 30 days total in the last 90 days prior to entry into Phase 1 for subjects entering Phase 1, or prior to Phase 2 for subjects entering Phase 2 directly after screening.

    Exclusion Criteria Assessed Prior to Entry into Phase 2
    23. Electroconvulsive therapy within 180 days prior to entry into Phase 2.

    Exclusion Criteria Assessed Prior to Entry into Phase 3
    24. Subjects who have not achieved stability criteria on oral aripiprazole for 4 consecutive weeks (2 consecutive bi-weekly visits) by Week 12 of Phase 2 or subjects who at Week 10 still do not meet stability criteria.

    Exclusion Criteria Assessed Prior to Entry into Phase 4
    25. Subjects who have more than one excursion from stability criteria after achieving a response to single-blind aripiprazole IM depot treatment at a point in the trial where they would not be able to maintain stability for a minimum of 12 weeks without exceeding 36 weeks total in Phase 3.
    26. Subjects who have not achieved stability criteria on aripiprazole IM depot for 12 consecutive weeks (6 consecutive bi-weekly visits) by Week 36 of Phase 3 or who have consecutive excursions at Weeks 26 and 28.
    27. Subjects who meet any of the criteria for exacerbation of psychotic symptoms/impending relapse prior to randomization. Such subjects are to be withdrawn from Phase 3 for lack of efficacy and not randomized into Phase 4.

    *See Protocol for explanatory details
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase 4, defined as meeting any or all of the following four criteria:

    1) CGI-Improvement of >=5 (minimally worse)

    AND
    • an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an absolute increase of >=2 on that specific item since randomization

    OR
    • an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 and an absolute increase of >=4 on the combined four PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) since randomization.

    OR
    2) Hospitalization due to worsening of psychotic symptoms (including partial hospitalization programs), but excluding hospitalization for psychosocial reasons

    OR
    3) CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2

    OR
    4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Provided in protocol
    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 months0
    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 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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1500
    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)
    Provided in 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 Decision2009-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-03
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