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    Clinical Trial Results:
    Functional effects of botulinum toxin in the hip adductors and subsequent exercise in patients with hereditary spastic paraplegia: a pilot RCT

    Summary
    EudraCT number
    		 2015-003184-11
    Trial protocol
    		 NL  
    Global end of trial date
    19 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    R0002820
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud university medical center
    Sponsor organisation address
    Reinier postlaan 4, Nijmegen, Netherlands,
    Public contact
    Investigator, Radboud University Medical Centre, Bas.vanLith@radboudumc.nl
    Scientific contact
    Investigator, Radboud University Medical Centre, Bas.vanLith@radboudumc.nl
    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
    10 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study is to investigate whether BTX injections, injected bilaterally in the spastic adductors of patients with HSP can improve lateral stepping and gait width.
    Protection of trial subjects
    The risk of participating in this study can be considered as negligible. There is a lot of knowledge about BTX-A and the rehabilitation physicians do have a lot of experience with BTX-A, even in smaller muscle groups. Burden associated with the measurements will be limited, since measurements were non-invasive and already clinically implemented.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2015
    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
    Netherlands: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    20
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion criteria Pure form HSP 18 years or older Bilateral hip adductor spasticity Balance- and gait-related activity limitations in daily life Able to walk >50 m Comfortable gait velocity >0.4 m/s Exclusion criteria: Cognitive impairments or comorbidity affecting gait capacity.

    Period 1
    Period 1 title
    T0
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    n.a.

    Arms
    Arm title
    		 BTX-A group
    Arm description
    		 There is one group, and its receiving BTX-A injections.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xeomin
    Investigational medicinal product code
    0259-1620
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Bilateral Xeomin injections (fixed dose of 400 U) in the hip adductors group under ultrasound guidance, using 4 injections each side: 2 injections in the m. adductor longus (2 x 50 U)and 2 injections in the m. gracilis (2 x 50 U) (solution: 100 U in 5 mlsaline 0,9%)

    Number of subjects in period 1
    		BTX-A group
    Started
    25
    Completed
    25
    Period 2
    Period 2 title
    T1
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BTX-A group
    Arm description
    		 There only was one group. It received BTX-A
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xeomin
    Investigational medicinal product code
    0259-1620
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Bilateral Xeomin injections (fixed dose of 400 U) in the hip adductors group under ultrasound guidance, using 4 injections each side: 2 injections in the m. adductor longus (2 x 50 U)and 2 injections in the m. gracilis (2 x 50 U) (solution: 100 U in 5 mlsaline 0,9%)

    Number of subjects in period 2 [1]
    		BTX-A group
    Started
    22
    Completed
    22
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: During T1, 3 patients were lost. Yet, I get an error message when this is filled in.
    Period 3
    Period 3 title
    T2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BTX-A group
    Arm description
    		 There was only one group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xeomin
    Investigational medicinal product code
    0259-1620
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Bilateral Xeomin injections (fixed dose of 400 U) in the hip adductors group under ultrasound guidance, using 4 injections each side: 2 injections in the m. adductor longus (2 x 50 U)and 2 injections in the m. gracilis (2 x 50 U) (solution: 100 U in 5 mlsaline 0,9%)

    Number of subjects in period 3
    		BTX-A group
    Started
    22
    Completed
    22

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    BTX-A group
    Reporting group description
    		 There is one group, and its receiving BTX-A injections.
    Reporting group title
    BTX-A group
    Reporting group description
    		 There only was one group. It received BTX-A
    Reporting group title
    BTX-A group
    Reporting group description
    		 There was only one group.

    Primary: Gait width

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    End point title
    		 Gait width
    End point description
    End point type
    Primary
    End point timeframe
    T0-T1-T2
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: centimeters
        arithmetic mean (standard deviation)
    10.7 ± 5.8
    11.8 ± 6
    11.3 ± 5.7
    Statistical analysis title
    		 RM - ANOVA
    Comparison groups
    BTX-A group v BTX-A group v BTX-A group
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Quality of sideways reactive stepping

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    End point title
    		 Quality of sideways reactive stepping
    End point description
    End point type
    Primary
    End point timeframe
    T0-T1-T2
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: angles
        arithmetic mean (standard deviation)
    18.7 ± 4.1
    19.8 ± 3.8
    19.3 ± 4.7
    Statistical analysis title
    		 ANOVA
    Comparison groups
    BTX-A group v BTX-A group v BTX-A group
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Gait width maximal speed

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    End point title
    		 Gait width maximal speed
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: angles
        arithmetic mean (standard deviation)
    10 ± 6
    11.5 ± 6.1
    11.2 ± 5.8
    No statistical analyses for this end point

    Secondary: Gait speed comfortable

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    End point title
    		 Gait speed comfortable
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: meter per second
        arithmetic mean (standard deviation)
    0.96 ± 0.25
    1.04 ± 0.25
    1.07 ± 0.28
    No statistical analyses for this end point

    Secondary: maximal gait speed

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    End point title
    		 maximal gait speed
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: meter per second
        arithmetic mean (standard deviation)
    1.31 ± 0.41
    1.33 ± 0.35
    1.36 ± 0.41
    No statistical analyses for this end point

    Secondary: Leg angle unknow direction

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    End point title
    		 Leg angle unknow direction
    End point description
    All outcome measure can be found in table 3 of the open access paper
    End point type
    Secondary
    End point timeframe
    Complete study
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: Rest
        arithmetic mean (standard deviation)
    19.1 ± 4.7
    19.3 ± 4.7
    19.4 ± 5.2
    No statistical analyses for this end point

    Secondary: Success rates known dir

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    End point title
    		 Success rates known dir
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    70 (45 to 90)
    90 (70 to 100)
    90 (55 to 100)
    No statistical analyses for this end point

    Secondary: Success rates unknown dir

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    End point title
    		 Success rates unknown dir
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study
    End point values
    		 BTX-A group BTX-A group BTX-A group
    Number of subjects analysed
    22
    22
    22
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    25 (0 to 55)
    35 (17.5 to 90)
    45 (0 to 70)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    T0-T1T2
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 n.a.
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There weren't any adverse events.

    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
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    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.

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