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    The EU Clinical Trials Register currently displays   35355   clinical trials with a EudraCT protocol, of which   5785   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-005585-40
    Sponsor's Protocol Code Number:A7501021
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-29
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2006-005585-40
    A.3Full title of the trial
    A randomized, parallel group, multiple dose, 6 week study to evaluate safety, tolerability, and pharmacokinetics of asenapine in elderly subjects with psychosis.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA7501021
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorNV Organon
    B.1.3.4CountryNetherlands
    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 nameAsenapine
    D.3.2Product code Org 5222
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNasenapine
    D.3.9.1CAS number 85650-56-2
    D.3.9.2Current sponsor codeOrg 5222
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 nameAsenapine
    D.3.2Product code Org 5222
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNasenapine
    D.3.9.1CAS number 85650-56-2
    D.3.9.2Current sponsor codeOrg 5222
    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: 3
    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 nameAsenapine
    D.3.2Product code Org 5222
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNasenapine
    D.3.9.1CAS number 85650-56-2
    D.3.9.3Other descriptive nameOrg 5222
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Acute and maintenance treatment of schizophrenia and manic episodes associated with bipolar I disorder.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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 6-weeks of asenapine up to doses of 10 mg BID in elderly subjects with psychosis.
    • To evaluate the pharmacokinetics of multiple dose administration of asenapine up to doses of 10 mg BID in elderly subjects with psychosis.
    E.2.2Secondary objectives of the trial
    • To explore the pharmacokinetic/pharmacodynamic relationship of asenapine in elderly subjects with psychosis.
    • To characterize tolerability of the 2 titration schedules.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria:
    Subjects should:

    1. be male or female subjects, 65 years of age or greater.

    2. willing to sign written informed consent (subjects unable or incapable of signing may participate if the legally authorized representative provides consent and the subject affirms their participation).

    3. be fluent in the language of the investigator, and study staff (including raters) and informed consent

    4. have a caregiver or an identified responsible person (eg, family member, social worker, caseworker or nurse) considered reliable by the investigator in providing support to the subject to ensure compliance with study treatment, outpatient visits, and protocol procedures.

    Diagnoses
    Subjects should:

    1. have psychotic symptoms as evidenced by a score of 4 or more on at least 1 of the following PANSS items:

    P1 Delusions
    P3 Hallucinatory behavior
    P4 Excitement
    P7 Hostility
    G14 Poor Impulse Control

    2. have a minimum PANSS total score >50 at screening.

    3. have a Clinical Global Impression – Severity of Illness (CGI S) scale score of at least 3 at screening.
    Pre-trial medication
    Subjects should:

    1. have responded positively to an antipsychotic medication other than clozapine (Clozaril®).

    2. have discontinued depot neuroleptics prior to first dose (Day 1) (last dose of depot neuroleptics should be received more than 1 dosing interval minus 1 week prior to first dose).

    E.4Principal exclusion criteria
    Subjects should be excluded from the trial if they:

    Psychiatric Exclusion Criteria

    1. have current (within 6 months prior to screening) DSM IV TR™ defined substance abuse/dependence (excluding nicotine and caffeine).

    2. have an established diagnosis of delirium according to DSM IV TR™ criteria.

    3. are at imminent risk of self-harm or are at risk of harming to others.

    4. have a score of 2 on any of items 7,10, or 11 on the Modified InterSePT scale for suicidal thinking (ISST).

    5. have a score of 17 or below on Mini Mental State Examination (MMSE).

    Medical Exclusion Criteria

    1. have an uncontrolled, unstable clinically significant medical condition (eg, renal, hepatic, endocrine, respiratory, cardiovascular, metabolic, hematologic, immunologic, cerebrovascular disease, anorexia or obesity [body mass index (BMI) ≤ 18.5 or >35] or malignancy), which, in the opinion of the investigator, may interfere with the interpretation of safety, efficacy, or pharmacokinetic evaluations. In case of BMI beyond the limits mentioned above, discussion should occur between the investigator and the sponsor before enrolling such subject(s) in the study.

    2. have jaundice or total bilirubin of >2X upper limit of normal (ULN).

    3. have any clinically significant abnormal laboratory, vital signs, physical examination, or electrocardiogram (ECG) findings at screening and any significant changes at randomization that, in the opinion of the investigator, precludes trial participation.

    4. have narrow angle glaucoma.

    5. have a seizure disorder beyond childhood or are taking any anticonvulsants to prevent seizures.

    6. have known serological evidence of HIV antibody.

    7. have a history of neuromalignant syndrome in the past 5 years.

    8. have a life-time history of cerebrovascular accident (e.g., documented history of stroke or TIA’s).

    9. have a history of myocardial infarction in past 5 years.

    10. have Parkinson’s disease.

    Medications

    1. have been judged by the principal investigator to be medically noncompliant in the management of their disease.

    2. have been judged by the principal investigator to be unable to reduce his or her daily benzodiazepine intake during inpatient phase to a maximum of 6 mg/day of lorazepam (or the equivalent dose of another short-acting benzodiazepine).

    3. have been treated with clozapine in the previous 6 months;
    4. have previously participated in an asenapine clinical trial.
    5. have taken an investigational drug within 30 days prior to first dose (Day 1).
    E.5 End points
    E.5.1Primary end point(s)
    There are not primary endpoints per se as there would be in an efficacy study. This is purely a safety study. Detailed methodology for summary and statistical analysis will be found in the Statistical Analysis Plan.
    Sample Size Determination
    120 subjects with a 20% drop out rate will likely yield exposure data on 100 elderly subjects
    Pharmacokinetic/pharmacodynamic modeling analysis
    - The relationship between asenapine exposure and PANSS and CGI-S scores will be investigated
    - Pharmacokinetic parameters such as Cmax, tmax, and AUC will be estimated from plasma concentration-time data
    - Descriptive statistics will be used to analyze concomitant medications, adverse events, changes in ESRS-A, lab values, and vital signs parameters
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Open label will be applicable from treatment day 5
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Asenapine in 2 different titration schedules
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    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 No
    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
    Willing to sign written informed consent (subjects unable or incapable of signing may participate if the legally authorized representative provides consent and the subject affirms their participation)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 120
    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)
    There are 2 follow-up visits that occur after dosing has stopped: one at 7 days to list conmeds and Adverse Events and one at 30 days to elicit any Severe Adverse Events that may have occurred. Subjects return to their pre-protocol care situation.
    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 Decision2007-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-20
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