Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-003331-36
    Sponsor's Protocol Code Number:FER-Loxapine-2015-01
    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:2015-12-04
    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 number2015-003331-36
    A.3Full title of the trial
    A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of self-administered ADASUVE(R) (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting
    Eine Phase IV, open-label, nicht-randomisierte, klinische Studie um die Sicherheit von selbstverabreichten ADASUVE® (Staccato loxapine zur Inhalation) in agitierten Patienten außerhalb des Krankenhaus zu beurteilen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Safety of self-administered ADASUVE (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting.
    A.4.1Sponsor's protocol code numberFER-Loxapine-2015-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02525991
    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 SponsorFERRER INTERNACIONAL SA
    B.1.3.4CountrySpain
    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 supportFERRER INTERNACIONAL SA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFERRER INTERNACIONAL SA
    B.5.2Functional name of contact pointThais Baleeiro Teixeira
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Diagonal, 549 3rd floor
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935082966
    B.5.5Fax number0034935044447
    B.5.6E-mailtbaleeiro@ferrer.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 Yes
    D.2.1.1.1Trade name ADASUVE®
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNloxapine
    D.3.9.1CAS number 1977-10-2
    D.3.9.3Other descriptive nameLOXAPINE
    D.3.9.4EV Substance CodeSUB08607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder
    E.1.1.1Medical condition in easily understood language
    Agitated patients with schizophrenia or bipolar disorder
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10001497
    E.1.2Term Agitation
    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 assess the safety profile of self-administered ADASUVE® outside the hospital setting in a population of patients that are known ADASUVE® responders and well trained on the use of the product, with a primary focus on serious adverse events (SAEs) and adverse events of special interest (AESI) related to ADASUVE®, including respiratory events.
    E.2.2Secondary objectives of the trial
    - To evaluate the time to improvement of the agitation episode after the self-adminsitration of ADASUVE® outside the hospital setting.
    - To analyse the patient-rated Clinical Global Impression-Improvement (CGI-I) scores up to 2 hours after the initial ADASUVE® self-administered dose outside of a hospital setting.
    - To evaluate the treatment satisfaction in ADASUVE® responders after the initial self-administered dose outside the hospital setting.
    - To describe the practice patterns for treating a worsening or no improvement of an agitation episode in the hospital setting after self-administration of ADASUVE®.
    - To analyse the degree of concordance between the patient/family
    member-caregiver and the physician in the diagnosis of the agitation
    episode/ administration of ADASUVE®.
    - To describe the patient profile and post-treatment outcomes of
    agitated patients/caregiver treated with ADASUVE® outside the hospital
    setting according to their level of agitation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients between the ages of 18-65 years, inclusive
    2. Patients (or legal representative) willing and able to provide written Informed Consent Form.
    3. Psychiatric patients already diagnosed of schizophrenia or bipolar disorder (according DSM-IV-TR, DSM-V or ICD-10 criteria).
    4. Patients with an on-going agitation episode (mild or moderate), or
    with a previous one within the 6 months prior to screening, attended and
    managed in the hospital setting.
    5. Previously treated with ADASUVE® with a positive outcome
    (responders) according to (CGI-I) scale (defined as having a CGI-I score
    of 1 or 2 at 2 hours after administration of the inhalation) or equivalent
    clinical evaluation at the discretion of the investigator and they have not
    developed bronchospasm after previous administration.
    6. Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease [COPD] or emphysema).
    7. Patient and/or caregiver/family able to:
    a. understand and follow a specific training for the administration of
    ADASUVE® outside the hospital setting,
    b. identify/detect a respiratory problem
    c. use of a bronchodilator if needed
    8. Requirement of family or other caregiver support at study investigator criteria (defined as a patient’s relative or caregiver (male or female) ≤ 80 year old, who spend ≥ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).
    9. Availability of patient’s medical records data about the previous treatment with ADASUVE® at hospital setting.
    10. If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.
    E.4Principal exclusion criteria
    1. Patient diagnosed with dementia.
    2. Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis).
    3. Patients with a history of allergic reactions to loxapine or amoxapine
    4. Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
    5. Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to assess the frequency of AEs related to ADASUVE®, with focus on SAEs and AESIs (including respiratory events) following the self-administration of ADASUVE® outside of a hospital setting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following the self-administration of ADASUVE outside of a hospital setting.
    E.5.2Secondary end point(s)
    - Incidence of other AEs-non respiratory AESIs related to ADASUVE® self-administration treatment outside the hospital setting.
    - Incidence of AEs, SAEs, AESIs and non-respiratory AESIs related to the second dose of ADASUVE® administered at the hospital setting (only in cases with a 2nd dose administration).
    - Time to onset of improvement of the current episode of agitation following the ADASUVE® self-administration outside the hospital setting.
    - Absolute CGI-I scores up to 2 hours after drug self-administration outside of a hospital setting.
    - Percentage of ADASUVE® responders, calculated as the proportion of
    patients who achieved a score of 1 ('very much improved') or 2 ('much
    improved') in CGI-Improvement scale at 2 hours after selfadministration
    of ADASUVE®. Patients' treatment satisfaction in ADASUVE® responders measured with a 5-point Likert scale at the end of the 24-74h follow-up period.
    - Patients’ treatment satisfaction in ADASUVE® responders measured with a 5-point Likert scale at the end of the 24-74h follow-up period.
    - Description of all anti-agitation medications administered at hospital setting (2nd dose of ADASUVE® or other treatments) for treating a worsening or no improvement of an agitation episode after self-administration of ADASUVE® outside the hospital setting.
    - Percentage of observed concordance and the degree of concordance
    between the patient/family member-caregiver and physician (clinical
    criteria) in identifying the severity of the agitation episode/
    administration of ADASUVE®.
    - Description of patients and family members/ caregivers´
    demographics, and clinical characteristics of agitated patients treated
    with ADASUVE® outside the hospital setting.
    - Description of possible differences in demographic and clinical profiles
    (diagnosis, disease status and agitation episode characteristics including
    symptoms of agitation), and post-treatment ADASUVE® outcomes
    among mild and moderate levels of agitation based on CGI-S scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Following the self-administration of ADASUVE® outside the hospital setting.
    - Following the second dose of ADASUVE® administered at the hospital setting (only in cases with a 2nd dose administration).
    - Following the ADASUVE® self-administration outside the hospital setting.
    - Up to 2 hours after drug self-administration outside of a hospital setting.
    - At 2 hours after self-administration of ADASUVE®.
    - At the end of the 24-74h follow-up period.
    - After self-administration of ADASUVE® outside the hospital setting.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The study will be finish when:
    - the last patient completes the follow-up period at 30 days after the self-administration of ADASUVE® outside the hospital setting,
    - or when last patient included has not presented a new episode of agitation up to the 6 months of follow-up from baseline visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.2.1Number of subjects for this age range: 500
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    Standard Medical Care
    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 Decision2015-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-31
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 11:16:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA