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   43861   clinical trials with a EudraCT protocol, of which   7284   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:2015-000749-21
    Sponsor's Protocol Code Number:4.20
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-30
    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 number2015-000749-21
    A.3Full title of the trial
    Botulinumtoxin A for emotional stabilization in borderline personality disorder
    Botulinumtoxin A zur emotionalen Stabilisierung bei der Borderline-Persönlichkeitsstörung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    n.a.
    A.3.2Name or abbreviated title of the trial where available
    BTX-BPD
    BTX-BPS
    A.4.1Sponsor's protocol code number4.20
    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 SponsorMedizinische Hochschule Hannover
    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 supportAsklepios Klinik Nord
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMedizinische Hochschule Hannover
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHCTC GmbH
    B.5.2Functional name of contact pointHannover Clinical Trial Center GmbH
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number00495115333330
    B.5.5Fax number004951153333399
    B.5.6E-mailinfo@clinical-trial-center.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 Bocouture
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBocouture (Botulinumtoxin A)
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeBotulinumtoxin A
    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
    Borderline personality disorder
    Borderline-Persönlichkeitsstörung
    E.1.1.1Medical condition in easily understood language
    n.a.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    The main objective of the trial is to test whether a single application of botulinumtoxin A into the Glabella will lead to emotional stabilization in borderline personality disorder through paralysis of facial muscles/attenuation of negative emotions.
    Ziel der Studie ist es, zu untersuchen, ob eine einmalige Anwendung von Botulinumtoxin A im Glabella-Bereich im Rahmen der Borderline Persönlichkeitsstörung durch Paralyse der Gesichtsmuskeln/Abschwächen negativer Emotionen zu einer emotionalen Stabilisierung führt.
    E.2.2Secondary objectives of the trial
    Investigate possible mechanisms of action
    Untersuchung von möglichen Wirkmechanismen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. female
    2. 18-40 years
    3. diagnosed BPD according to ICD-10 (F60.31) and SKID II
    4. stable treatment
    5. mastery of the German language
    6. effective contraception (in accordance to the „note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals“, CPMP/ICH/286/95 mod); these inculde contraception methods with a failure rate of less than 1% given correct administration (e.g. hormonal implants, hormonal injections (depot), combined oral contraceptives, IUDs, s/p partners' vasectomy))
    7. willingness to and acceptance of treatment with either Bocouture or acupuncture
    1. weibliches Geschlecht
    2. 18 bis 40 Jahre
    3. nach den Kriterien des ICD10 (F60.31) und gemäß SKID II diagnostizierte BPS
    4. stabile Behandlung (siehe Abschnitt 5.2. Umgang mit Vormedikation)
    5. sichere Beherrschung der deutschen Sprache
    6. ausreichend effektive Empfängnisverhütung (im Sinne der „Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals“, CPMP/ICH/286/95 mod); dazu zählen Verhütungsmethoden mit einer Versagensrate von weniger als 1 % bei regelmäßiger und korrekter Anwendung wie z.B. Hormonimplantate, Hormoninjektionen (Depotspritzen), kombinierte orale Kontrazeptiva, bestimmte Intrauterinpessare (IUDs), sexuelle Abstinenz oder Z.n. Vasektomie des Partners)
    7. Bereitschaft zu und Akzeptanz von einer Behandlung mit Bocouture® oder Akupunktur
    E.4Principal exclusion criteria
    1. Comorbid disorders of all ICD-10 groups
    o F0,
    o F1 (with exception of F1x.1),
    o F2,
    o F3 (with exception of 32.0 and F33.0),
    o F7
    and disorders essentially defining the clinical picture from sections
    o F4,
    o F5,
    o F6.
    2. Contraindication for treatment with Botulinumtoxin A accoring to the IMP's SmPC (e.g. myasthenia gravis, Lambert Eaton-syndrome or other impairments in neuromuscular function)
    3. Pregnancy and nursing period
    4. earlier treatment with Boulinumtoxin A
    5. acute suicidal tendencies
    6. severe suicide attempt during the last 6 month
    7. infections and skin problems at the injection site
    8. facial nerve palsy in anamnesis
    9. facial asymmetry
    10. ptosis
    11. extremely slack skin
    12. strong scars
    13. thick tallowy skin
    14. acute or anamnestic neurological disorders (esp. s/p stroke and/or TIA
    15. intake of medication impairing swallowing, speech, breath or affecting salivary production
    16. different from aesthetically motivated treatment, the Glabella frown line must not be perceived as overly burdening (rating on a 5-point Likert scale) in order to keep influences of a patient's changed perception of her own appearance to a minimum)
    17. severe health or social problems that call continuous attendance into question
    18. acute psychotherapeutic structured specific treatment (e.g. DBT)
    19. intake of medication affecting the muscle tonus
    20. change of treatment (medication or psychotherapy) less than 8 weeks before inclusion
    21. participation in other clinical trials (as per AMG) during the last 6 months
    22. presence of relevant impairment of vigilance (sedation) or muscle tonus (extrapyramidal symptoms) caused by generally permitted medication
    1. alle komorbiden Störungen der ICD-10 Gruppen
    o F0 (psychische Störungen mit organischer Grundlage),
    o F1 (Störungen durch psychotrope Substanzen; mit Ausnahme von F1x.1 – schädlicher Gebrauch psychotroper Substanzen),
    o F2 (Schizophrenie-Spektrumsstörungen),
    o F3 (Affektive Störungen; mit Ausnahme von F32.0 (leichte depressive Episode) und F33.0 (rezidivierende depressive Störung, gegenwärtig leichte Episode)),
    o F7 (Intelligenzstörungen) sowie
    o das klinische Gesamtbild maßgeblich prägende Störungen der Gruppen F4 (Neurotische, Belastungs- und somatoforme Störungen, z.B. Zwangsstörungen),
    o F5 (Verhaltensauffälligkeiten mit körperlichen Störungen und Faktoren, z.B. Schlafstörungen) und
    o F6 (Persönlichkeits- und Verhaltensstörungen).
    2. Kontraindikationen gegen eine Behandlung mit Botulinumtoxin A gemäß der Fachinformation des verwendeten Präparats (z.B. Myasthenia gravis, Lambert Eaton-Syndrom oder andere Störungen der neuromuskulären Funktion),
    3. Schwangerschaft und Stillzeit
    4. frühere Behandlungen mit Botulinumtoxin A
    5. akute Suizidalität
    6. schwerer Suizidversuch in den letzten 6 Monaten
    7. Infektionen oder Hautprobleme an der Injektionsstelle
    8. Fazialislähmung in der Anamnese
    9. ausgeprägte Asymmetrie des Gesichts
    10. Ptosis
    11. extreme Schlaffhaut
    12. tiefe Hautnarben
    13. dicke talgige Haut
    14. neurologische Grunderkrankungen oder solchen Erkrankungen in der Vorgeschichte (dies gilt insbesondere für Patientinnen nach Schlagfanfall und/oder TIAs)
    15. Einnahme von Medikamenten, welche die Schluck-, Sprech- und Atemfunktion beeinträchtigen oder sich auf die Speichelproduktion auswirken
    16. anders als bei einer kosmetisch motivierten Behandlung darf die Glabellafalte von den einzelnen Patientinnen nicht als kosmetisch übermäßig störend empfunden werden (Einschätzung mithilfe einer 5-stufigen Likert-Skala), um Einflüsse einer veränderten Bewertung des eigenen Erscheinungsbildes möglichst gering zu halten
    17. schwerwiegende gesundheitliche oder soziale Probleme, welche eine kontinuierliche Teilnahme an der Studie von vornherein infrage stellen. Befinden sich die Patientinnen
    18. aktuelle Teilnahme an einer strukturierten, störungsspezifischen Psychotherapie (wie z.B. der DBT)
    19. Einnahme von Medikamenten mit relevantem Einfluss auf den Muskeltonus
    20. Veränderung der Behandlung (medikamentös oder psychotherapeutisch) vor weniger als 8 Wochen
    21. Teilnahme an anderen klinischen Studien gem. AMG innerhalb der letzten 6 Monate
    22. Vorliegen einer relevanten Beeinträchtigung der Vigilanz (Sedierung) oder des Muskeltonus (extrapyramidale Symptome) durch die Einnahme von grundsätzlich zulässigen Medikamenten
    E.5 End points
    E.5.1Primary end point(s)
    Zanarini Rating Scale for borderline personality disorder (ZAN-BPD)
    Zanarini Rating Skala für Borderline Persönlichkeitsstörung (ZAN-BPS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks after treatment
    8 Wochen nach Behandlung
    E.5.2Secondary end point(s)
    Borderline-Symptom-List 23 (BSL-23)
    Borderline-Symptom-Liste 23 (BSL-23)
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 8 and 16 weeks after treatment
    4, 8 und 16 Wochen nach Behandlung
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    Akupunktur
    acupuncture
    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 concerned2
    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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 54
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    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)
    not different from expected normal treatment
    nicht verschieden von erwarteter normaler Behandlung
    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 Decision2016-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-10
    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-Thu Apr 25 23:56:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA