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    Summary
    EudraCT Number:2011-002048-29
    Sponsor's Protocol Code Number:RGH-MD-06
    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:2011-11-03
    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
    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 number2011-002048-29
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel-group study of
    cariprazine (RGH-188) in the prevention of relapse in patients with
    schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safe and effective cariprazine in preventing relapse for patients with schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    Relapse prevention in patients with schizophrenia
    A.4.1Sponsor's protocol code numberRGH-MD-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01412060
    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 SponsorForest Research Institute, 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 supportForest Research Institute, USA
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGedeon Richter Plc
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus
    B.5.3.2Town/ cityRosebank, Livingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailEudraCT_Info@quintiles.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 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 nameCariprazine
    D.3.2Product code RGH-188
    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 INNCariprazine HCl
    D.3.9.1CAS number 839712-12-8
    D.3.9.2Current sponsor codeRGH-188 HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4.0
    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, hard
    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
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 and safety of cariprazine (RGH-188) relative to
    placebo in the prevention of relapse of symptoms in patients with
    schizophrenia
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written (signed or thumb printed in accordance with local regulations to ensure protection of patient’s rights) informed consent obtained from the patient before the initiation of any study-specific procedures
    2. Male or female inpatient, 18 to 60 years of age, inclusive
    3. Current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (295.30 Paranoid Type, 295.10 Disorganized Type, 295.20 Catatonic Type, or 295.90 Undifferentiated Type) as determined by the Structured Clinical Interview for DSM-IV (SCID)
    4. Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
    5. Current psychotic episode < 4 weeks duration at Visit 1
    6. PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2
    7. Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms; delusions, hallucinatory behavior, conceptual disorganization, suspiciousness/persecution at Visit 1 and Visit 2
    8. Patients who are capable of being compliant with self-administration of medication
    9. Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (applies to female patients of childbearing potential only)
    10. Normal physical examination findings, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
    11. Body mass index between 18 and 40 kg/m2, inclusive (rounded to nearest whole number)
    12. Patients must be able to speak and understand the local language sufficiently to understand the nature of the study
    E.4Principal exclusion criteria
    1. Currently meeting DSM-IV-TR criteria for some diseases (see protocol)
    2. Patients in their first episode of psychosis
    3. Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug’s package insert)
    4. Positive result from the blood alcohol test or from the urine drug screen (UDS) for any prohibited medication
    5. History of intolerance or hypersensitivity to a typical or atypical antipsychotic or to designated rescue medications or any history of severe drug allergy or hypersensitivity
    6. At imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
    7. Suicide risk
    8. Electroconvulsive therapy in the 3 months before Visit 1
    9. Previous lack of response to electroconvulsive therapy
    10. Treatment with a depot neuroleptic within 1 cycle before Visit 1
    11. Treatment with clozapine in the past 10 years (exceptions: 1. Episodic use of clozapine at doses ≤ 100 mg/day for the treatment of insomnia. 2. For non-US countries only, with prior approval from the Forest Medical Monitor or designee, past use of clozapine at doses ≤ 350 mg/day as treatment for schizophrenia symptoms in patients who had not demonstrated treatment resistance or intolerance to other antipsychotics and who did not require it for the treatment of suicidality)
    12. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal products, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component
    13. At Visit 2, requiring pharmacologic treatment for the control of EPS
    14. Prior participation in any investigational study of cariprazine (RGH-188)
    15. Women who meet the following criteria:
    - Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during the study
    - Not at least 2 years postmenopausal, surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing a reliable method of contraception that will continue for the duration of the study.
    16. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
    17. Any cardiovascular disease that is clinically significant, unstable, or decompensated.
    18. Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 3 months before Visit 1
    19. Psychiatric symptoms possibly secondary to any other general medical condition (eg, Vitamin B-12/folate deficiency, Cushing syndrome, etc)
    20. Gastric bypass or any condition that would be expected to affect drug absorption (gastric banding procedures are acceptable if not associated with absorption problems)
    21. History of seizure disorder, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes the patient toward a risk for seizure
    22. Known history of cataracts, a finding of cataract at the screening ophthalmologic examination, or presence of any LOCS III findings at the screening ophthalmologic examination
    23. Patients who meet some ophthalmologic criteria
    24. Known human immunodeficiency virus infection
    25. Positive test for hepatitis C infection
    26. Positive test for hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M
    27. Liver enzyme test results (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) > 2 × the upper limit of normal
    28. History of tardive dyskinesia (except for mild cases attributed to use of conventional agents), serotonin syndrome, or neuroleptic malignant syndrome
    29. History of syndrome of inappropriate antidiuretic hormone secretion
    30. Treatment with any investigational product within the 6 months (or at least 5 half-lives, whichever is longer) before Visit 1
    31. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
    32. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent (signed or thumbprinted in accordance with local regulations to ensure protection of patient’s rights), and to allow the completion of all study assessments
    33. Unable or unlikely to comply with the study protocol or are unsuitable for any other reason, as judged by the PI
    E.5 End points
    E.5.1Primary end point(s)
    Time to first relapse during the DBP
    Relapse during the DBP will be defined as meeting any one or more of the following criteria:
    1. Psychiatric hospitalization due to worsening of the patient’s underlying condition
    2. Increase in PANSS total score by ≥30% for patients who scored 50 or higher at randomization or a 10-point or more increase for patients who scored less than 50 at randomization (Note: Patient should meet this criterion at a second assessment that is 4 to 7 days apart [exception: Based on severity for safety reasons the PI has discretion
    not to perform a second assessment])
    3. Increase in the Visit 14 CGI-S score by 2 or more points (Note: Patient should meet this criterion at a second assessment that is 4 to 7 days apart [exception: Based on severity for safety reasons the PI has discretion not to perform a second assessment])
    4. Deliberate self-injury or aggressive/violent behavior
    5. Suicidal or homicidal ideation that was clinically significant as judged by the PI
    6. Score of greater than 4 on 1 or more of the following PANSS items: P1, P2, P3, P6, P7, G8 or G14 (Note: Patient should meet this criterion at a second assessment that is 4 to 7 days apart [exception: Based on severity for safety reasons the PI has discretion not to perform a second assessment])
    Relapse
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to Relapse
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Argentina
    Bulgaria
    Colombia
    India
    Philippines
    Romania
    Slovakia
    Ukraine
    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
    Last Patient, Last Visit
    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 months10
    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 months10
    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: 900
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 900
    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)
    Patients who complete the study, or who prematurely discontinue from the study will be
    followed for 4 more weeks and will have 2 evaluations for safety assessments at the end
    of Visit 53 and 54 during SFU period. During the SFU, patients will continue as
    outpatients and will receive treatment as usual at the discretion of the PI or designee.
    Patients will not receive IP during the SFU.
    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 Decision2012-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-27
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