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    Clinical Trial Results:
    Botulinumtoxin A for emotional stabilization in borderline personality disorder

    Summary
    EudraCT number
    		 2015-000749-21
    Trial protocol
    		 DE  
    Global end of trial date
    10 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2024
    First version publication date
    03 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BOTOX III
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02728778
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hannover Medical School
    Sponsor organisation address
    Carl-Neuberg-Str. 1, Hannover, Germany, 30625
    Public contact
    Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.de
    Scientific contact
    Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigation of glabellar injections of Botulinumtoxin A in treatment of borderline personality disorder
    Protection of trial subjects
    The clinical trial was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and with the standards of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    53
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient/trial person diagnosed with borderline personality disorder (ICD 10: F60.31)

    Pre-assignment
    Screening details
    		 Eligibility will be determined based upon the inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    There is a blinded and an unblinded team at each study center. The unblinded team does the injections and the unblinded team is responsible for the psychometrical rating. participants are not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Acupuncture
    Arm description
    		 Four treatments of acupuncture at intervals of 2 weeks.
    Arm type
    		 acupuncture control group

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Botulinum toxin
    Arm description
    		 Single intramuscular injection of Bocouture®-solution at five sites of Mm. corrugatores supercilii et procerus with a sterile 0.3 ml insulin syringe (30 gauge)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botulinumtoxin A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single intramuscular injection of Bocouture®-solution at five sites of Mm. corrugatores supercilii et procerus with a sterile 0.3 ml insulin syringe (30 gauge)

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Blinding is only single blind and the psychometrical rating was done by a blinded assessor team
    Number of subjects in period 1
    		Acupuncture Botulinum toxin
    Started
    26
    27
    Completed
    19
    23
    Not completed
    7
    4
         Hospitalization
    1
    -
         Discontinued
    5
    -
         Lost to follow-up
    -
    4
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Acupuncture
    Reporting group description
    		 Four treatments of acupuncture at intervals of 2 weeks.

    Reporting group title
    Botulinum toxin
    Reporting group description
    		 Single intramuscular injection of Bocouture®-solution at five sites of Mm. corrugatores supercilii et procerus with a sterile 0.3 ml insulin syringe (30 gauge)

    Reporting group values
    		 Acupuncture Botulinum toxin Total
    Number of subjects
    		 26 27 53
    Age categorical
    Participants with diagnosed BPD; female sex, age 18–40 years, stable treatment for at least 8 weeks prior to and after enrollment
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27.96 ( 5.74 ) 30.44 ( 5.80 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 27 53
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Acupuncture
    Reporting group description
    		 Four treatments of acupuncture at intervals of 2 weeks.

    Reporting group title
    Botulinum toxin
    Reporting group description
    		 Single intramuscular injection of Bocouture®-solution at five sites of Mm. corrugatores supercilii et procerus with a sterile 0.3 ml insulin syringe (30 gauge)

    Primary: Increase in ZAN-BPS values

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    End point title
    		 Increase in ZAN-BPS values
    End point description
    The primary efficacy endpoint is the relative increase in ZAN-BPS values from week 8 to baseline, compared between the treatment groups (BTX treatment versus ACU control) and adjusted for centers (Hamburg versus Hannover). As defined in the protocol the relative difference between ZAN-BPS scores at baseline za0 and at week 8 za8 is compared between the treatment groups. The null hypothesis of no difference between the groups is examined.
    End point type
    Primary
    End point timeframe
    visits occur at week 2, 4, 6, 8, 12 and 16
    End point values
    		 Acupuncture Botulinum toxin
    Number of subjects analysed
    23
    24
    Units: : Differences in mean values of ZAN-BPS
        arithmetic mean (standard deviation)
    -0.346 ( 0.418 )
    -0.388 ( 0.389 )
    Statistical analysis title
    		 equality of treatment means
    Statistical analysis description
    ANOVA Table (type II test): increase in ZAN-BPS between treatment
    Comparison groups
    Acupuncture v Botulinum toxin
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.68
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Der Dokumentationszeitraum für diese Klinische Prüfung beginnt mit der einmaligen Verabreichung des Prüfpräparates und endet mit der letzten Visite (16 Wochen nach Verabreichung).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Acupuncture
    Reporting group description
    		 -

    Reporting group title
    Botulinumtoxin A
    Reporting group description
    		 -

    Serious adverse events
    		 Acupuncture Botulinumtoxin A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 26 (7.69%)
    4 / 27 (14.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Cholezystektomie
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Borderline Persoenlichkeitsstoerung
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suizidgedanken
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Acupuncture Botulinumtoxin A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 26 (38.46%)
    15 / 27 (55.56%)
    Injury, poisoning and procedural complications
    Absichtliche Ueberdosis
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    3
    Bandruptur
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Kontusion
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Kopfschmerz im Zusammenhang mit einem Verfahren
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Cardiac disorders
    Arrhythmie
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Nervous system disorders
    Kopfschmerzen
         subjects affected / exposed
    4 / 26 (15.38%)
    5 / 27 (18.52%)
         occurrences all number
    5
    9
    Migraene
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Schwindelgefuehl
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Sprachstoerung
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Akne an der Applikationsstelle
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Ermuedung
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Schmerzen an der Injektionsstelle
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nichtinfektioese Gingivitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergisch
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Lichtempfindlichkeitsreaktion
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Absichtliche Selbstverstuemmelung
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    4
    Einschlafstoerung
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Schlafstoerung
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 27 (3.70%)
         occurrences all number
    1
    1
    Trauerreaktion
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgie
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Genitaler Herpes
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 27 (3.70%)
         occurrences all number
    1
    1
    Otitis externa
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35102782
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