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    Clinical Trial Results:
    Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo-controlled pilot study

    Summary
    EudraCT number
    2016-003939-38
    Trial protocol
    FR  
    Global end of trial date
    23 Apr 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Jun 2022
    First version publication date
    19 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P160404J
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03187626
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Sponsor organisation address
    DRCI Hôpital Saint-Louis, 1 avenue Claude Vellefaux, PARIS, France, 75010
    Public contact
    DRCI Hôpital St Louis, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), josephine.braun@aphp.fr
    Scientific contact
    AP-HP Hôpital Cochin, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), christelle.nguyen2@aphp.fr
    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
    12 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy on pain at 3 months of a single ultrasound-guided intra-articular injection of (botulinum toxin A) BTA associated with splinting to a single ultrasound-guided intra-articular injection of saline associated with splinting in patients with painful Base-of-thumb osteoarthritis (BTOA)
    Protection of trial subjects
    Patients benefit from specific medical monitoring and the single trapezio-metacarpal intra-articular infiltration, i.e. at the base of the thumb, is performed under ultrasound by an experienced radiologist. AP-HP has taken all measures to conduct this research in accordance with the provisions of the Public Health Code applicable to research involving humans.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Nov 2018
    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
    France: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    34
    From 65 to 84 years
    24
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Participants to be recruited among patients seen in hospital consultation and rehabilitation hospitalization at Cochin Hospital and presenting with rhizarthrosis as well as among the patients of the DIGICODE digital osteoarthritis cohort (Hôpital Saint-Antoine) and the employees of the AP-HP via the intranet and the AP mailing list -HP

    Pre-assignment
    Screening details
    Participants will be recruited from outpatients and those seen in hospital consultations, occupational therapy consultations, or full or partial hospitalization in physical medicine and rehabilitation (PMR) at Hôpital Cochin with rhizarthrosis

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    botulinum toxin
    Arm description
    Experimental
    Arm type
    Experimental

    Investigational medicinal product name
    toxine botulinique de type A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    50 units, administered in a single intra-articular, trapezoidal-metacarpal, ultrasound-guided injection performed by an experienced radiologist

    Arm title
    Placebo
    Arm description
    Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1 ml NaCl 0,9%, administered in a single intra-articular, trapezoidal-metacarpal, ultrasound-guided injection performed by an experienced radiologist

    Number of subjects in period 1
    botulinum toxin Placebo
    Started
    30
    30
    Completed
    30
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    botulinum toxin
    Reporting group description
    Experimental

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Reporting group values
    botulinum toxin Placebo Total
    Number of subjects
    30 30 60
    Age categorical
    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)
    65.2 ± 8.2 64.6 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    25 22 47
        Male
    5 8 13

    End points

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    End points reporting groups
    Reporting group title
    botulinum toxin
    Reporting group description
    Experimental

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Subject analysis set title
    intent to treat
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    intent to treat

    Primary: Change in base of thumb pain score at 3 monts

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    End point title
    Change in base of thumb pain score at 3 monts
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    botulinum toxin Placebo
    Number of subjects analysed
    30
    30
    Units: number from 0 to 100
        arithmetic mean (confidence interval 95%)
    -25.7 (-35.5 to -15.8)
    -9.7 (-17.1 to -2.2)
    Statistical analysis title
    Statistical analysis
    Comparison groups
    botulinum toxin v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05 [1]
    Method
    Constrained longitudinal data analysis
    Confidence interval
    Notes
    [1] - p<0.05 Constrained longitudinal data analysis Chi-squared test Fisher's exact test

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    experimental
    Reporting group description
    -

    Reporting group title
    placebo
    Reporting group description
    -

    Serious adverse events
    experimental placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    experimental placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 30 (90.00%)
    24 / 30 (80.00%)
    Vascular disorders
    Localised bleeding
    Additional description: bleeding
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Thenar muscle motor deficit
    Additional description: Motor dysfonction
         subjects affected / exposed
    14 / 30 (46.67%)
    2 / 30 (6.67%)
         occurrences all number
    14
    2
    Thumb paraesthesia
    Additional description: paresthesia of fingers
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Base-of-thumb pain
    Additional description: Pain in thumb
         subjects affected / exposed
    6 / 30 (20.00%)
    11 / 30 (36.67%)
         occurrences all number
    6
    11
    Other musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    5 / 30 (16.67%)
    6 / 30 (20.00%)
         occurrences all number
    5
    6
    Infections and infestations
    Intercurrent infection
    Additional description: Infection NOS
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2018
    Modification of the data collection at 1 month in the protocol and in the information note: patients will complete the information concerning health status and medication consumption and the pain scale at the +1 month visit
    26 Jun 2018
    - clarification of non-inclusion criteria to "Neurological conditions affecting the hand other than carpal tunnel syndrome" and "Osteoarthritis predominating at the scaphotrapezial joint on radiographs - Modification of the practical conduct of the study by grouping the inclusion visit and the infiltration visit on the same day - Correction of the type of orthesis used: The ortheses usually used for rhizarthrosis are thermoformed plastic ortheses - Modification of the practical procedure by adding the collection of AEs at M1 at the request of the ANSM - Addition of the self-questionnaire for the collection of adverse events
    28 May 2019
    - 6-month extension of the duration of inclusions - Compliance of the paragraphs relating to the processing of health data with the legislative and regulatory framework of the GDPR
    07 Feb 2020
    - 6-month extension of the duration of inclusions - Addition of a non-inclusion criterion: "Patient with epilepsy": in accordance with the product's SmPC - Addition of the credibility questionnaire to the follow-up at 6 months
    28 Jul 2020
    6-month extension of the duration of inclusions

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Mar 2020
    inclusions suspended due to the COVID-19 pandemic from 16.03.2020, resumed on 02.06.2020
    02 Jun 2020

    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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