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    Summary
    EudraCT Number:2014-004474-42
    Sponsor's Protocol Code Number:V3_06082015
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-004474-42
    A.3Full title of the trial
    Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.
    Behandling af equinus gang som følge af dynamisk lægmuskelstramning hos børn med cerebral parese. Et randomiseret, placebo-kontrolleret Botulinum toxin type A volumen/respons studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of gait problems caused by spastic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.
    Behandling af spidsfodsgang som følge af spastisk lægmuskelstramning hos børn med spastisk lammelse. Et randomiseret, placebo-kontrolleret Botulinum toxin type A volumen/respons studie.
    A.4.1Sponsor's protocol code numberV3_06082015
    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 SponsorCopenhagen University Hospital at Hvidovre
    B.1.3.4CountryDenmark
    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 supportHelene Elsass Fonden
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital Hvidovre
    B.5.2Functional name of contact pointChristian Wong
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Alle 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538826966
    B.5.6E-mailchwoforsk@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 BOTOX® (onabotulinumtoxinA)
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameBOTOX® (onabotulinumtoxinA)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBotulinum toxin A
    D.3.9.3Other descriptive nameBOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
    D.3.9.4EV Substance CodeSUB77183
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 6
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy.
    E.1.1.1Medical condition in easily understood language
    Gait problems caused by spasticity in the calf muscles in children with cerebral palsy.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10015112
    E.1.2Term Equinus deformity of foot, acquired
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine how two different volumes of botox in the triceps surae (mm. gastrocnemii lateralis et medialis and if necessary m. soleus) affect the efficacy of the treatment compared to placebo measured by improved gait function (three dimensional gait analysis).
    E.2.2Secondary objectives of the trial
    Non applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Spastic cerebral palsy diagnosed by a neuro-pediatrician
    - Spasticity/increased tone in m. triceps surae
    - 3-8 years of age
    - GMFCS level I or II
    E.4Principal exclusion criteria
    Lacking ability to cooperate and take part in three-dimensional gait analysis
    - More than five previous BoNT-A treatments or insufficient effect of the latest treatment
    - Hypersensitivity caused by BoNT-A or one or more of the ancillary substances
    - Infection at the intended injection site
    - Injection treatment with BoNT-A within the previous four months
    - Operations in the lower extremities within the previous year
    - Planned operations in the lower extremities, that is deemed to interfere with research outcome parametres during the project period
    E.5 End points
    E.5.1Primary end point(s)
    Three-dimensional gait analysis:
    - Maximum dorsiflexion in the ankle joint during stance
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 1-2 weeks before first injection
    2: 4-6 weeks after first injection

    3: 1-2 weeks before second injection
    4: 4-6 weeks after second injection

    5: 1-2 weeks before third injection
    6: 4-6 weeks after third injection
    E.5.2Secondary end point(s)
    Three-dimensional gait analysis:
    - Maximum gastrocnemius length
    - Changes in external knee extension and internal ankle plantarflexor moments
    - Walking speed, step length, symmetry

    Others:
    - Foot function (pedobarography)
    - Muscle activity (EMG)
    - PROM/AROM (ankle, knee and hip joints)
    - Spasticity (modified Ashworth, Portable Spasticity Assessment Device*)
    - Gross Motor Function Measure, dimension D & E.
    - Pediatric Evaluation of Disability Inventory (PEDI)
    - Muscle volume/thickness (m. gastrocnemius and m. soleus) measured by ultrasound before each injection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 1-2 weeks before first injection
    2: 4-6 weeks after first injection

    3: 1-2 weeks before second injection
    4: 4-6 weeks after second injection

    5: 1-2 weeks before third injection
    6: 4-6 weeks after third injection

    - Muscle volume/thickness (m. gastrocnemius and m. soleus) will be measured by ultrasound before each injection. The measurement will be performed with reference to the anatomical levels described by Berweck et Heinen (2005).
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Volume/response
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Own control by recording outcome parametres before and after treatment.
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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
    Last Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 Yes
    F.1.1Number of subjects for this age range: 26
    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: 26
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children below the age of 9 years, some with cognitive handicaps.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 26
    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, usual care.
    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 Decision2015-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-24
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