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    Summary
    EudraCT Number:2008-002699-83
    Sponsor's Protocol Code Number:31-08-248
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-002699-83
    A.3Full title of the trial
    A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients with Schizophrenia

    "ASPIRE OPEN-LABEL" (Aripiprazole Intramuscular Depot Progam in Schizophrenia)
    A.3.2Name or abbreviated title of the trial where available
    ASPIRE OPEN-LABEL
    A.4.1Sponsor's protocol code number31-08-248
    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
    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 safety and tolerability of aripiprazole IM Depot administered every 4 weeks for 52 weeks to patients with schizophrenia
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, as measured by the proportion of stable subjects at baseline who remain stable at endpoint and impact on social functioning, of aripiprazole IM depot administered every 4 weeks for 52 weeks to patients with schizophrenia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Direct Entry Into Study 248 After Studies 246/247

    Entry into Phase 2
    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
    - are Male/female 18-65 years of age, inclusive, at the time of informed consent
    - have completed 246/247 or who were withdrawn from the double-blind phase of either study for any reason (*) and did not receive any antipsychotic treatment(s) other than aripiprazole monotherapy after participation in 246/247 *
    - in the investigator’s judgment, require chronic treatment with an antipsychotic medication and would benefit from extended treatment with an IM depot formulation
    - have =<30 days between the completion/discontinuation date from 246/247 and the enrollment date into 248 *
    - have had adequate washout of prohibited concomitant medications *
    - have inpatient or outpatient status
    - are able to understand the nature of the study and follow protocol requirements, including: prescribed dosage regimens/tablet ingestion/IM depot injection/restrictions on concomitant medications/can read and understand the written word in order to complete patient-reported outcomes measures/can be reliably rated on assessment scales

    Entry into Phase 3
    Subjects who:
    - have outpatient status
    - meet ALL of the following criteria on at least one occasion after receiving at least four weeks of treatment with oral aripiprazole at a dose of 10 to 30 mg: Outpatient status; PANSS Total Score =< 80; 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; CGI-S =<4 (moderately ill); CGI-SS =<2 (mildly suicidal) on Part 1 and =<5 (minimally worsened) on Part 2

    Entry After Last Visit of 246/247 and Additional Subjects
    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
    - are male/female 18-65 years of age, inclusive, at time of informed consent
    - are currently diagnosised with schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening*
    - in the investigator’s judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation
    - showed previous response to antipsychotic treatment (other than clozapine) in the past year, according to the investigator’s opinion
    - are currently being treated with oral or depot antipsychotics other than clozapine (*) and who, in the investigator’s judgment, require chronic treatment with an antipsychotic medication and would benefit from treatment with aripiprazole IM depot
    - have inpatient or outpatient status prior to entry into Phase 3*
    - are able to understand the nature of the study and follow protocol requirements, including: prescribed dosage regimens/tablet ingestion/IM depot injection/restrictions on concomitant medications/can read and understand the written word in order to complete patient-reported outcomes measures/can be reliably rated on assessment scales

    Entry into Phase 1:
    Subjects who:
    - have had adequate washout of prohibited concomitant medications*
    - is receiving no more than one benzodiazepine beyond screening*
    - has inpatient or outpatient status
    - is receiving antipsychotic(s) other than non-generic oral aripiprazole or clozapine and must be cross-titrated to aripiprazole monotherapy (study drug)*

    Entry into Phase 2:
    Subjects who:
    - have had adequate washout of prohibited concomitant medications*
    - 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. *
    - has inpatient/outpatient status

    Entry into Phase 3:
    Subjects who:
    - 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.
    - has outpatient status
    - meets ALL of the following criteria on at least one occasion after receiving at least four weeks of treatment with oral aripiprazole at a dose of 10 to 30 mg: Outpatient status; PANSS Total Score =< 80; 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; CGI-S =< 4 (moderately ill); CGI-SS =< 2 (mildly suicidal) on Part 1 and =< 5 (minimally worsened) on Part 2

    *see protocol for explanatory details
    E.4Principal exclusion criteria
    Direct Entry After Studies 246/247

    Entry into Phase 2
    Subjects who:
    - are sexually active males/females of childbearing potential, not practicing double-barrier birth control, or who will not remain abstinent during the study and for 180 days (for males) and 150 days (for females) following the last dose of study medication. If employing birth control, two of the precautions (*listed int he protocol) must be used
    - are females who have a positive serum pregnancy test prior to receiving study drug
    - are receiving any antipsychotic(s) other than oral aripiprazole monotherapy (study drug) after completion/withdrawal from 246/247*
    - are currently receiving or likely to require prohibited concomitant therapy during the trial*
    - are currently receiving CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers or anticipated use of such agents during the trial*
    - have had electroconvulsive therapy since concluding participation in 246/247

    Entry into Phase 3
    Subjects who:
    - receive at least four consecutive weeks of treatment with oral aripiprazole monotherapy int he range of 10-30mg daily and do not achieve stability criteria on at least one occasion between Week 4 and Week 16 of Phase 2

    Entry After Last Visit of 246/247 + Additional Subjects
    Subjects:
    - who are sexually active males/females of child-bearing potential who are not practicing double-barrier birth control or who will not remain abstinent during the study and for 180 days (for males) and 150 days (for females) following the last dose of study medication. If employing birth control, two of the precautions (*listed in protocol) must be used
    - who are females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug
    - with a current DSM-IV-TR diagnosis other than schizophrenia*
    - experiencing acute depressive symptoms within the past 30 days, according to the investigator’s opinion, that requires treatment with an antidepressant
    - with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history
    - with a history of failure to clozapine treatment or response to clozapine treatment only
    - with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator’s judgment
    - who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine
    - with known hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days)
    - who have a history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial*
    - with epilepsy or a history of seizures, except for a single childhood febrile seizure, post traumatic, alcohol withdrawal, etc
    - with two positive drug screens for cocaine prior to Phase 2*
    - with the following laboratory test, vital sign, and ECG results are exclusionary: platelets =< 75,000/mm3; hemoglobin =<9 g/dL; neutrophils, absolute =<1000/mm3; AST > 3x upper limit of normal; ALT > 3x upper limit of normal; Creatinine >= 2 mg/dL; Diastolic blood pressure > 105 mmHg--QTc > 475 msec *
    - who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones
    - with a history of hypersensitivity to antipsychotic agents
    - who are known to be allergic, intolerant, hypersensitive, or refractory to antipsychotic agents
    - with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening
    - likely to require prohibited concomitant therapy during the trial*
    - receiving CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers at screening or anticipated use of such agents during the trial*
    - 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 than 246/247*

    Other Exclusion Criteria
    - Prisoners or subjects who are compulsorily detained (*) for treatment of either a psychiatric or physical illness*
    - 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

    Entry into Phase 2
    - Electroconvulsive therapy within 180 days prior to entry into Phase 2

    Entry into Phase 3
    - Subjects who receive at least four consecutive weeks of treatment with oral aripiprazole monotherapy in the range of 10 to 30 mg daily and do not achieve stability criteria on at least one occasion between Week 4 and Week 16 of Phase 2.

    *See protocol for explanatory details
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the percentage of stable subjects at baseline who remain stable at endpoint, where “stable” is defined as meeting ALL of the following criteria:
    1) Outpatient status AND
    2) PANSS Total Score =< 80 AND
    3) Lack of specific psychotic symptoms on the PANSS as measured by a score of =< 4 on each of the following items (possible scores of 1 to 7 for each item):
    · conceptual disorganization
    · suspiciousness
    · hallucinatory behavior
    · unusual thought content AND
    4) CGI-S =< 4 (moderately ill) AND
    5) CGI-SS =< 2 (mildly suicidal) on Part 1 and =< 5 (minimally worsened) on Part 2
    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 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) 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 No
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA144
    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 years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 800
    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 Decision2009-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-07
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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