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    Summary
    EudraCT Number:2015-000682-30
    Sponsor's Protocol Code Number:01-09.02.15.
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-16
    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 ConcernedEstonia - SAM
    A.2EudraCT number2015-000682-30
    A.3Full title of the trial
    Botulinum neurotoxin type A treatment for sialorrhea in central nervous system diseases
    LIIGSE SÜLJEERITUSE RAVI BOTULISMITOKSIINIGA NEURODEGENERATIIVSETE HAIGUSTEGA PATSIENTIDEL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    How affect the salivary gland treatment with Botulinum neurotoxin type A oral health in patients suffer for drooling?
    Kuidas muudab süljenäärmete ravi botulismitoksiini süstidega süljeerituse käes vaevlevate patsientide suuõõne tervist?
    A.4.1Sponsor's protocol code number01-09.02.15.
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTartu University Hospital
    B.1.3.4CountryEstonia
    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 supportTartu University Hospital Clinic
    B.4.2CountryEstonia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTartu University Hospital Clinic
    B.5.2Functional name of contact pointTartu University Hospital Clinic
    B.5.3 Address:
    B.5.3.1Street AddressPuusepa 8
    B.5.3.2Town/ cityTartu
    B.5.3.3Post code51014
    B.5.3.4CountryEstonia
    B.5.6E-mailjanne.tiigimae-saar@kliinikum.ee
    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.2.1.2Country 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.3.2Product code Clostridium botulinum type A toxin
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraglandular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNToxinum Clostridii botulinii
    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 U unit(s)
    D.3.10.2Concentration typeequal
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypersalivation
    Liigne süljeeritus on sage probleem neuroloogilise häirega patsientidel nagu näiteks tserebraalparalüüsiga lapsed ja amüotroofse lateraalskleroosiga patsiendid.
    Hüpersalivatsioon on samuti sage Parkinsoni tõvega patsientide sümptom, esinedes peaaegu 75% patsientidest.
    E.1.1.1Medical condition in easily understood language
    drooling
    Liigne süljeeritus
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10020746
    E.1.2Term Hypersalivation
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.Evaluate and compare salivary compositions and microflora change after BNT-A injections describing the status of caries and periodontal health.
    2. Evaluate the BNT-A efficiency in treatment of average and hard sialorrhea patients.
    3. Evaluate the BNT-A effect on patients life-quality.
    Uuringu põhieesmärk on hinnata sülje koostise ja mikrofloora muutust ja võrrelda näitajaid kontrollgrupiga.
    E.2.2Secondary objectives of the trial
    The primary objective is to compare salivary compositions and microflora change after BNT-A injections describing the status of caries and periodontal health and to compare thease relates to controls.
    Hinnata Botulismitoksiin A ravi efektiivsust ja ohutust keskmise ja raske süljeeritusega patsientide ravis.
    Hinnata patsientide elukvaliteedi muutust.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    BNT-A injections into salivary glands is used to treat patients suffering average and hard hypersalivation.
    • The aetiology of sialorrhea is caused by chronic neurodegenerative diseases.
    • The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)
    • The cases when logopedical treatment with chewing muscle and m. orbicularis oris myogymnastics do not decrease the saliva flow.

    The first control group participants are selected during routine dentist visits at Tartu University Hospital
    • Requirement is that they have to be healthy human volunteers with the same age group.

    The second control group are selected during routine neurologist visits.
    • Parkinson´s disease patients without sialorrhea. The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)
    Uuringugrupi patsiendid valitakse keskmise ja raske süljeeritusega patsientide hulgast.
    • Hüpersalivatsiooni põhjus on neurodegeneratiivne haigus.
    • Süljeerituse raskust hinnatakse vastava andmestiku järgi [Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)]
    • Kui patsiendile pole eelnevalt logopeediline või mälumislihaste ja suu ringlihaslihase (m. orbicularis oris) müogümnastika olulist süljevooluse vähenemist toonud.

    Esimese kontrollgrupi patsiendid valitakse rutiinse hambaarsti visiidi käigus Tartu Ülikooli Kliinikumis.
    • Terved, samaealised vabatahtlikud.

    Teises kontrollgrupis osalejad valitakse rutiinse neuroloogi visiidi käigus Tartu Ülikooli Kliinikumis.
    • Parkinsoni tõvega patsiendid kellel liigset süljeeritust ei esine. Süljeerituse aste määratakse vastava astmestiku järgi [Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)]
    E.4Principal exclusion criteria
    • During the study, no medication that could influence the severity of drooling is allowed.
    • Patients with other sialorrhea treatment will be excluded from the study.
    • Uuringusse ei võeta patsiente kes tarvitavad ravimeid, mis võivad mõjutada süljeeritust.
    • Samuti ei kaasata patsiente kellel kasutatakse mõnda muud hüpersalivatsiooni ravimeetodit.
    E.5 End points
    E.5.1Primary end point(s)
    1. The study group patients get their BNT-A injections because of sialorhhea treatment despite of investigation. Control groups do not get any BNT-A injections.
    2. Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference.
    3. Treatment efficacy and safety were assessed with questionnaire at baseline, and at one month after the BNT-A injections follow-up, using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) and side effects surveillance (Mancini et al., 2003).
    4. Study group will be interviewed by questionnaire twice: before and 1 month after the BNT-A treatment to investigate the changes in life quality.
    1. Uuringugrupi patsiendid saavad BNT-A süstidega süljenärmete ravi hoolimata läbiviidavast uuringust.
    Kontrollgrupi osalejad BNT-A süste ei saa.
    2. Süljeteste tehakse kõikidele uuringus osalejatele kaks korda ühe kuuse vahega. Uuringugrupi patsientidele tehakse süljetestid enne ja 1 kuu pärast BNT-A süste. Kontrollgrupi liikmetele tehakse testid kaks korda ühe kuuse vahega.
    3. Ravi efektiivsust hinnatakse küimustiku alusel enne ja 1 kuu pärast BNT-A süstidega ravi. Kasutatakse spetsiaalset andmestikku [Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) and side effects surveillance (Mancini et al., 2003).]
    4. Elukvaliteeti hinnatakse samuti küsimustiku alusel kaks korda enne ja 1 kuu pärast süstimist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference.
    Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference.
    E.5.2Secondary end point(s)
    Salivary tests will be done to all the participants twice with one month difference. Study group is tested with salivary tests before and one month after the BNT-A injections. Control groups will be tested with salivary tests twice with one month difference.
    1. Ravi efektiivsust hinnatakse küimustiku alusel enne ja 1 kuu pärast BNT-A süstidega ravi. Kasutatakse spetsiaalset andmestikku [Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) and side effects surveillance (Mancini et al., 2003).]
    2. Elukvaliteeti hinnatakse samuti küsimustiku alusel kaks korda enne ja 1 kuu pärast süstimist.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment efficacy and safety were assessed with questionnaire at baseline, and at one month after the BNT-A injections follow-up, using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008) and side effects surveillance (Mancini et al., 2003).
    Study group will be interviewed by questionnaire twice: before and 1 month after the BNT-A treatment to investigate the changes in life quality.
    1 kuu
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.2.3.1Comparator description
    Sülje muutust võrreldakse BNT-A süste mittesaanud Parkinsoni tõvega ja tervete kontrollgrupiga
    not treated with BNT-A injections
    E.8.2.4Number of treatment arms in the trial1
    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
    Last visit of the last subject undergoing the trial
    Viimase osaleja viimane uuringuvisiit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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
    Some persons with Parkinson disease and children could not speak or write correct because of main disease
    Mõned neuroloogilise häirega patsiendid ei ole võimelised oma põhihaiguse tõttu korrektselt rääkima või kirjutama.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    If BNT-A injections do not have positive effect, the patient´s treatment with BNT-A will be stopped
    Kui BNT-A ravi ei ole tulemust andnud, siis ravi lõpetatakse. Toime möödub iseenesest 4 kuu möödudes.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Tartu University Hospital
    G.4.3.4Network Country Estonia
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-12
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