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    Summary
    EudraCT Number:2018-002499-42
    Sponsor's Protocol Code Number:Version1on02-02-2018
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-002499-42
    A.3Full title of the trial
    Evaluation of the effect of repeated injections of high doses of botulinum toxin into the lower limb of spastic brain lesions on functional and biomechanical parameters of walking
    Évaluation de l’effet d’injections répétées de hautes doses de toxine botulique dans le membre inférieur de sujets cérébrolésés spastiques sur les paramètres fonctionnels et biomécaniques de marche
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effect of repeated injections of botulinum toxin into the lower limb.
    A.4.1Sponsor's protocol code numberVersion1on02-02-2018
    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 SponsorCliniques Universitaires Saint-Luc
    B.1.3.4CountryBelgium
    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 supportCliniques Universitaires Saint-Luc
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques Universitaires Saint-Luc
    B.5.2Functional name of contact pointGaetan Stoquart
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Hippocrate 10
    B.5.3.2Town/ cityBrussel
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number003227641649
    B.5.6E-mailgaetan.stoquart@uclouvain.be
    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 Xeomeen
    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 nameXeomeen
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXeomeen
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
    D.3.9.4EV Substance CodeSUB26174
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Patients with spastic brain lesions.
    Children with cerebral palsy (CP) and in the hemiplegic adult.
    E.1.1.1Medical condition in easily understood language
    Patients with spastic brain lesions.
    Children with cerebral palsy (CP) and in the hemiplegic adult.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    1. Demonstrate that repeated injections of high-dose botulinum toxin significantly improve the functional functioning of hemiplegic spastic adult patients compared to single-dose, moderate-dose injections.
    2. Demonstrate the validity of the low-cost KI-Gait walk analysis system, based on the Kinect infrared camera device, in children with cerebral palsy (CP) and in hemiplegic adults.








    Demonstrate that repeated injections of high-dose botulinum toxin significantly improve the functional functioning of hemiplegic spastic patients compared to single-dose, moderate-dose injections




    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Demonstrate the validity of the low-cost KI-Gait walk analysis system, based on the Kinect infrared camera device, in children with cerebral palsy (CP) and in hemiplegic adults.
    E.3Principal inclusion criteria
    1. adults (> 18 years)
    2.hemiparesis after first stroke, delay after stroke> 6 months
    3. limb-gait spasticity
    4.ability to perform treadmill walking tests, indication of focal chemical denervation
    Sub-study :
    1. old: > 4 and <18 years,
    2.cerebral palsy (spastic hemiplegia, diplegia or quadriplegia)
    3. Gross Motor Function Classification System (GMFCS) <4.
    E.4Principal exclusion criteria
    1. aphasia or major cognitive impairment limiting functional evaluation
    2. neurological or orthopedic problem interfering with the function of the lower limb studied
    3. injections of botulinum toxin in the lower limb less than 5 months old
    4.contraindication to botulinum toxin (neuromuscular disease under -cente)
    5.contraindication to performing an MRI.
    E.5 End points
    E.5.1Primary end point(s)
    Functional assessments will be based on the WHO International Classification of Functioning, Disability and Health.
    Assessment by clinical exam and by NMR
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluations will be done at Mont 1, month 3 and month 6.
    E.5.2Secondary end point(s)
    Impairments will be assessed using clinical examination (evaluation of range of motion by manual goniometry, spasticity by modified Ashworth and Tardieu scales, evaluation of motor control by the Fugl-Meyer test), by functional data (10-meter fast-running speed, modified 6-minute test22, timed rise and fall test, 23 Timed Up and Go Test24) and AQM. Activity limitations will be assessed using the ABILOCO25 questionnaire. The quality of life of patients will be evaluated by the French version of Short-Form Health Survey SF-36.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluations will be done at Mont 1, month 3, month 4, month 6 and month 7.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Medical need program
    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 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
    After the visit dont at month 7.
    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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state330
    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)
    All patients will be followed by their medical doctors after the participation at this clinical trial in standard care
    No children will receive injections of toxin botulinum but only walking tests.
    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 Decision2018-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
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