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    Summary
    EudraCT Number:2021-005723-20
    Sponsor's Protocol Code Number:RC31/20/0445
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-15
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2021-005723-20
    A.3Full title of the trial
    Evaluation of Botulinum TOXin type A in the treatment of Buerger’s disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Botulinum TOXin type A in the treatment of Buerger’s disease
    A.3.2Name or abbreviated title of the trial where available
    BETOX
    A.4.1Sponsor's protocol code numberRC31/20/0445
    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 SponsorCHU de Toulouse
    B.1.3.4CountryFrance
    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 supportCHU Toulouse
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Toulouse
    B.5.2Functional name of contact pointClinical Research Associate
    B.5.3 Address:
    B.5.3.1Street Address2 rue Viguerie TSA 80035
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number561778597+33
    B.5.5Fax number561778411+33
    B.5.6E-mailtomasik.audrey@gmail.com
    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 Botulinum toxin type A
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPercutaneous use (Noncurrent)
    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 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
    This study assesses the feasibility and safety of treatment with botulinum toxin injection in patients with Buerger's disease
    E.1.1.1Medical condition in easily understood language
    This study assesses the feasibility and safety of treatment with botulinum toxin injection in patients with Buerger's disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess the feasibility and safety of treatment by injecting botulinum toxin A into each hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A into each hand or foot is performed after a single session, in day hospitalization. Tolerance is assessed before, during and 2 hours after the injection.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the impact of the injection of botulinum toxin A in each hand or foot at the end of a session, at 1 month, 3 months and 6 months on:
    - critical hemodynamic ischemia parameters (toe pressure or finger pressure, TCPO2
    - the intensity of the pain (VAS)
    - healing of distal ulcers
    -the number of new digital ulcers
    - the number of minor or major amputations,
    - the frequency and severity of Raynaud's syndrome associated with Buerger's disease
    - life quality
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age 18 years
    2) patient with Buerger’s disease according to Olin criteria (ref)
    3) with digital ischemia with critical upper or lower limb ischemia criteria (3) Upper limb: pain and/or trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) Lower limb: pain and/or trophic disorders for at least 15 days AND ankle pressure less than 50 mmHg (70 mmHg if diabetes), or 30 mmHg at the toe ( 50 mmHg if diabetes) or TCPO2 30 mmHg).
    4) Ability to attend study visits
    5) Ability to complete daily study agenda
    6) Ability to give free and informed consent
    7) Membership of a Social Security scheme
    E.4Principal exclusion criteria
    1) History of myasthenia gravis or Eaton-Lambert syndrome
    2) History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy. 3) Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.
    4) Progressive infection of one hand or foot
    5) Pregnant or nursing women
    6) History of vascular surgery of surgical sympathectomy of upper or lower limb
    7) Risk of major amputation within 3 months of inclusion
    8) Iloprost expected within one month of study treatment
    9) hyperbaric chamber sessions scheduled within one month of study treatment
    10) life expectancy less than 6 months
    11) Cognitive impairment
    12) Patient under guardianship, curatorship, protection of justice
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is feasibility as well as tolerance.
    The feasibility criterion corresponds to the number of patients who actually received the injections planned within the defined timeframes, compared to the number of patients who should have had the injection according to the criteria of the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after injection Botulinum toxin
    E.5.2Secondary end point(s)
    1 / Critical ischemia parameters:
    Doppler laser tissue perfusion assessment, toe pressure or finger pressure in mmHg before (D0) and after injection (M1, M3, M6)
    Evaluation of tissue perfusion by thermal camera before (D0) and after injection (M1, M3, M6)
    Transcutaneous measurement of the partial pressure of oxygen TCPO2 before (J0) and after injection (M1, M3, M6)
    2 / Pain assessed by the EVA at M1, M3, M6
    3 / Evaluation of the healing of distal ulcers (D0, M1, M3, M6)
    - color scale (% of bud, fibrin, necrosis, epidemization) at D0, M1, M3, M6
    - dimension, surface of ulcers at D0, M1, M3, M6
    - new distal ulcerations on D0, M1, M3, M6
    - number of ulcers whose surface area has reduced by more than 40% at M1, M3, M6
    - number of total healing (100% epidermis) at M1, M3, M6
    - number of minor or major amputations at M1, M3, M6
    4 / Appearance of new digital ulcers
    5 / Need for minor and major amputation
    6 / Frequency and severity of Raynaud's syndrome associated with Buerger's disease according to the Raynaud condition score (J0, M1, M3, M6) A seizure is defined as a paroxysmal episode of pallor or cold cyanosis (with or without pain, tingling or numbness). Patients will note the number and duration of RA attacks on a daily basis as well as the severity of the RA, each attack is self-assessed daily on a 10-point scale and the average calculated over 14 days ± 4 days, from day D-14 to day D0 (+/- 4 days) and from day D14 to day D28 (+/- 4 days)
    7 / Quality of life questionnaire (EQ-5D-5L, Cochin, Claus) on D0 and M6
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after injection Botulinum toxin
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 months6
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    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)
    None
    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 Decision2022-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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