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    Summary
    EudraCT Number:2014-005440-17
    Sponsor's Protocol Code Number:LOX_2015_PILOT
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-005440-17
    A.3Full title of the trial
    Tolerability and analgesic efficacy of Loxapine in patients with refractory, chemotherapy-induced neuropathic pain
    Verträglichkeit und analgetische Wirksamkeit von Loxapin bei Patienten mit therapierefraktären, Zytostatika-induzierten neuropathischen Schmerzen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tolerability of Loxapine in patients with anti-cancer drug induced pain
    A.4.1Sponsor's protocol code numberLOX_2015_PILOT
    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 SponsorPrivate Universität Witten/Herdecke gGmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPrivate Universität Witten/Herdecke gGmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportLannett Company, Inc., Philadelphia, PA 19136
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHELIOS Klinikum Wuppertal, Klinikum der Privaten Universität Witten/Herdecke
    B.5.2Functional name of contact pointPhilipp Klee-Institut
    B.5.3 Address:
    B.5.3.1Street AddressHeusnerstrasse 40
    B.5.3.2Town/ cityWuppertal
    B.5.3.3Post codeD-42283
    B.5.3.4CountryGermany
    B.5.4Telephone number00492028961854
    B.5.5Fax number00492028961852
    B.5.6E-mailwup-aerzte-pharmakologie@helios-kliniken.de
    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 Loxapine Capsules 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderLannett Company, Inc., Philadelphia, PA 19136
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLoxapine Capsules 10 mg
    D.3.4Pharmaceutical form Capsule
    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 INNLoxapine
    D.3.9.1CAS number 27833-64-3
    D.3.9.3Other descriptive nameLOXAPINE SUCCINATE
    D.3.9.4EV Substance CodeSUB02977MIG
    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) 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
    Chemotherapy-induced neuropathic pain
    E.1.1.1Medical condition in easily understood language
    Pain induced by anti-cancer drugs
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tolerability of Loxapine in patients with chemotherapy-induced neuropathic pain
    E.2.2Secondary objectives of the trial
    Analgesic efficacy of Loxapine in patients with chemotherapy-induced neuropathic pain
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Chemotherapy induced neuropathic pain of at least 3 months refractory to at least one analgesic compound
    - Neuropathic pain ≥ 4 (11-point numeric pain rating scale) at screening visit (including mixed pain)
    - Age: ≥18 years
    - Body weight between 50 to 150 kg
    - Given written informed consent
    E.4Principal exclusion criteria
    - Participation in other interventional studies (current or within the last 3 months)
    - Parkinson’s disease, movement disorders (extrapyramidal signs and symptoms) associated with antipsychotics, Neuroleptic malignant syndrome, other syndromes associated with antipsychotics
    - Severe hypotension with a syncope in history, glaucoma, urinary retention, epilepsy or other seizure disorders in history, severe dementia, dementia related psychosis in history, breast cancer in medical history, malignancies with a life expectancy of less than 6 months, other severe and life-threatening diseases
    - Known drug or alcohol abuse
    - Concomitant intake of antipsychotics, dopamine agonists (levodopa, bromocriptine, lisuride, pergolide, ropinirole, cabergoline, pramipexole, apomorphine), alpha-receptor blocking compounds or compounds with a known potential for QT interval prolongation
    - Pregnancy or lactation period
    - Pre- or perimenopausal females with ineffective contraception
    - Close affiliation with the investigational site
    E.5 End points
    E.5.1Primary end point(s)
    This pilot study is a safety study primarily evaluating the tolerability of Loxapine in non-psychiatric patients. The primary endpoint is defined as the first occurrence of a (serious) adverse event leading to dose reduction or withdrawal of Loxapine ("event"). The Loxapine dosage with the lowest incidence of events will be identified.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints will be analyzed after all planned patients have finished the study (no planned interim analyses).
    E.5.2Secondary end point(s)
    Regarding tolerability, the following secondary safety variables will be analyzed:
    - Number, type, and severity of (serious) adverse events ((S)AEs)
    - Cumulative incidence rates for (S)AE pattern of study participants
    - Individual (study participant-related) incidence of individual (S)AEs

    Regarding efficacy, the following secondary variables will be analyzed:
    - Individual (study participant-related) changes in pain severity (measured by using a 11-point numeric pain rating scale) in relation to treatment phase and Loxapine dosage
    - Assessment of the association between the pattern of events (primary endpoint) related to the individual pain level (Clinically relevant pain reduction is defined by an at least 30% decrease or an absolute decrease of two scale units (measured by using 11-point numeric pain rating scale)
    - Individual (study participant-related) changes in pain severity / characteristics (measured by painDETECT questionnaire) in relation to treatment phase and Loxapine dosage
    - Assessment of the association between the pattern of events (primary endpoint) related to individual changes in pain severity / charcteristics (measured by painDETECT questionnaire)
    - Individual (study participant-related) changes in the quality of life (12-item Short Form Health Survey (SF-12v2)) in relation to treatment phase and Loxapine dosage
    - Assessment of the association between the pattern of events (primary endpoint) related to the individual quality of life changes ((12-item Short Form Health Survey (SF-12v2))
    - Individual (study participant-related) changes in anxiety and depression (HADS-D scale)) in relation to treatment phase and Loxapine dosage
    - Assessment of the association between the pattern of events (primary endpoint) related to the individual changes in anxiety and depression (HADS-D scale)
    - Assessment of the association between the pattern of events (primary endpoint) related to the individual changes analgesic co-medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be analyzed after all planned patients have finished the study (no planned interim analyses).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Dose-escalating
    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 No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    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)
    Since in this study Loxapine is used as add-on analgesic treatment, patients will be treated after the end of study according to usual care and guidelines. If Loxapine was efficacious and well tolerated, Loxapine can be prescribed by treating physicians on their responsibility and can be ordered by an international pharmacy.
    Nach Behandlungsende erfolgt die weitere analgetische Therapie durch die behandelnden Ärzte. Falls Loxapin gut verträglich und analgetisch wirksam war, kann es durch die behandelnden Ärzte im Rahmen eines individuellen Heilversuches verordnet werden und über eine internationale Apotheke bezogen werden. Die Überprüfung der Verordnungsfähigkeit und der Erstattungsfähigkeit liegt in der Verantwortung der weiterbehandelnden Ärzte.
    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 Decision2015-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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