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    Summary
    EudraCT Number:2015-003184-11
    Sponsor's Protocol Code Number:R0002820
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-20
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-003184-11
    A.3Full title of the trial
    Functional effects of botulinum toxin in the hip adductors and subsequent exercise in patients with hereditary spastic paraplegia: a pilot RCT
    Functionele effecten van botulinetoxine in de heup adductoren en daaropvolgende oefeningen bij patiënten met HSP: een pilot RCT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Functional effects of botulinum toxin in the hip adductors and subsequent exercise in HSP patients
    Functionele effecten van botulinetoxine in de heup adductoren en daaropvolgende oefeningen bij HSP patiënten.
    A.3.2Name or abbreviated title of the trial where available
    FEBOCH-II
    FEBOCH-II
    A.4.1Sponsor's protocol code numberR0002820
    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 SponsorRadboud University Medical Centre
    B.1.3.4CountryNetherlands
    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 supportRadboud University Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Centre
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressReinier Postlaan 2
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GC
    B.5.3.4CountryNetherlands
    B.5.6E-mailBas.vanLith@radboudumc.nl
    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 Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharma Benelux B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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
    Hereditary Spastic Paraplegia
    Hereditaire Spastische Paraplegie
    E.1.1.1Medical condition in easily understood language
    HSP
    HSP
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    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.
    De primaire doelstelling van deze studie is te onderzoeken of BTX injecties, bilateraal geïnjecteerd in de spastische adductoren van HSP patiënten, lateraal stappen en de loopbreedte kan verbeteren.
    E.2.2Secondary objectives of the trial
    The secondary objectives are balance confidence, Berg Balance Scale, comfortable and maximum overground gait velocity, 6-Min Walk Test, Timed Up and Go test and gait adaptability.
    The secundaire doelstellingen zijn de balans tevredenheid, Berg Balans Schaal, comfortabele en maximale loopsnelheid, 6-Min Loop Test, Time Up and Go test en aanpassingsvermogen tijdens lopen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -diagnosis of pure HSP based on molecular diagnosis (e.g. SPG-4 mutations) or based on inheritance
    -age at least 18 years
    -suffer from (bilateral) hip adductor spasticity without contracture (modified Ashworth scale score 1-4)
    -being a minimally independent household ambulator without walking aid (Functional Ambulation Categories 4-5)
    -gait velocity > 0.4 m/s
    -complain of balance problems due to a narrow base of support or problems with lateral stepping
    -diagnose van pure HSP gebaseerd op moleculaire diagnose (bijv. SPG-4) of op basis van erfelijkheid
    -minimaal 18 jaar
    -Lijden aan (bilaterale) heup adductor spasticiteit zonder contractuur (modified Ashworth scale score 1-4)
    -minimaal onafhankelijke lopers in bekende omgeving zonder hulpmiddelen (Functional Ambulation Categories 4-5)
    -Loopsnelheid > 0.4 m/s
    -Klachten over balansproblemen door te kleine standbreedte of problemen met zijwaarts stappen
    E.4Principal exclusion criteria
    -Last BTX treatment of the hip adductors is shorter than 6 months ago or when a next BTX treatment of these muscles cannot be postponed for 4 months without increasing fall risk or jeopardizing patients’ safety in any other way.
    -Any previous BTX injections in the calf muscles are accepted, but it must be possible to safely postpone subsequent injections of these muscles for 4 months after inclusion
    -Insufficient vision
    -Insufficient cardiopulmonary endurance
    -Insufficient sensorimotor abilities
    -Laatste BTX behandeling van de heup adductoren korter dan 6 maanden geleden of wanneer een BTX behandeling van deze spieren niet uitgesteld kan worden naar 4 maanden na inclusie zonder het risico van vallen te vergroten of de patiënt op enige andere wijze in gevaar te brengen
    -Voorgaande BTX injecties in kuitspieren worden geaccepteerd, maar het moet mogelijk zijn deze veilig uit te stellen naar 4 maanden na inclusie.
    -Onvoldoende visie
    -Onvoldoende cardiopulmonaal uithoudingsvermogen
    -Onvoldoende sensorimotorische capaciteiten
    E.5 End points
    E.5.1Primary end point(s)
    Increased succesratio of recovering balance by a lateral step. Increased frontal leg angle. Increased gait width
    Verhoogde succes-ratio in balanshandhaving door een zijwaartse stap. Verhoogde frontale beenhoek. Verbeterde loopbreedte
    E.5.1.1Timepoint(s) of evaluation of this end point
    before, 6 weeks and 16 weeks after the injection
    voor, 6 en 16 weken na de injectie
    E.5.2Secondary end point(s)
    Increased balance confidence, gait velocity and gait adaptability
    Verhoogde balans tevredenheid, loopsnelheid en aanpassingsvermogen tijdens het lopen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    before, 6 weeks and 16 weeks after the injection
    voor, 6 en 16 weken na de injectie
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 30
    F.1.3Elderly (>=65 years) No
    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 state30
    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
    geen
    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 Decision2015-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-19
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