Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-004795-19
    Sponsor's Protocol Code Number:120824001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-28
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-004795-19
    A.3Full title of the trial
    Utilisation of botulinum toxin type A on masticatory muscel hyperactivity in CP - a randomized, controlled study.
    Utvärdering av injektioner med botulinum toxin vid tuggmuskulär hyperaktivitet hos individer med cerebral pares.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Utilisation of botulinum toxin type A on masticatory muscel hyperactivity in CP.
    Utvärdering av injektioner med botulinum toxin vid tuggmuskulär hyperaktivitet hos individer med cerebral pares.
    A.3.2Name or abbreviated title of the trial where available
    Botox studie
    A.4.1Sponsor's protocol code number120824001
    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 SponsorFolktandvården Västra Götaland
    B.1.3.4CountrySweden
    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 supportFolktandvården Västra Götaland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFolktandvården Västra Götaland
    B.5.2Functional name of contact pointBirgitta Johansson Cahlin
    B.5.3 Address:
    B.5.3.1Street AddressBiskopsbogatan 27
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post code43180
    B.5.3.4CountrySweden
    B.5.4Telephone number+46031861500
    B.5.6E-mailbirgitta.johansson-cahlin@vgregion.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Allergan
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNBotulinum Toxin type A
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Masticatory muscle hyperactivity/bruxism in patients with Cerebral Palsy.
    Tuggmuskulär hyperaktivitet/bruxism hos personer med cerebral pares.
    E.1.1.1Medical condition in easily understood language
    Masticatory muscle hyperactivity/bruxism in patients with Cerebral Palsy.
    Tuggmuskulär hyperaktivitet/bruxism hos personer med cerebral pares.
    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 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10028037
    E.1.2Term Movement disorders (incl parkinsonism)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to evaluate if injections with botulinum toxin in persons with cerebral palsy and severe bruxism/parafunction in masticatory muscles reduce the bite force without any adverse effects.
    Huvudsyftet med studien är att utvärdera om injektioner med botulinum toxin hos personer med cerebral pares och svår bruxism/hyperaktiv i tuggmuskulaturen reducerar bitmuskelstyrkan utan negativa biverkningar.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    - To evaluate if it is possible to identify responders after one injection
    - Patient-reported outcomes including bruxism, pain, chewing- and speech ability and oral health-quality of life
    - To evaluate mandibular movements in function, before and after injcection
    Sekundära syften är:
    - Att ta reda på om man redan efter en injektion kan identifiera responders
    - Att ta reda på patientens bedömning av bruxism, smärta, tugg- och talförmåga och munhälsa- livskvalitet
    - Att utvärdera underkäkens rörelsemönster vid funktion, före och efter injektion
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willingness to participate
    2. Female and male aged 18 years or older
    3. CP with masticatory muscle hyperactivity/bruxism
    4. Obvious tooth wear
    5. Capabillity to decide
    1. Villig att delta
    2. Kvinnor och män 18 år eller äldre
    3. CP med tuggmuskulär hyperaktivitet/bruxism
    4. Tydligt tandslitage
    5. Fullt beslutskapabel
    E.4Principal exclusion criteria
    1. Inability to understand the study and complete the questionnaire
    2. Patients with known hypersensitivity to Botox
    3. Patients with any infection in the injection site
    4. Treatment with BTX-A injection last month
    5. Medication with aminoglycoside antibiotics, spectinomycin and neuromuskular blockers
    1. Oförmåga att förstå studien och svara på frågeformulären
    2. Individer med känd överkänslighet mot botulinumtoxin typ A eller något hjälpämne
    3. Vid infektion vid det planerade injektionsstället
    4. Behandling med BTX-A, oavsett kroppsdel, senaste månaden
    5. Medicinering med aminoglykosida antibiotika, spektinomycin och neuromuskulära blockerare
    E.5 End points
    E.5.1Primary end point(s)
    - Bite force, measured with a bite fork, peak at maximal clenching during 3 sec, mean of 3 tests.
    - Bite force as "chewing", measured with a bite fork, mean of 5 tests.
    - Bitkraften, mätt med en bitkraftsmätare där en bitgaffel placeras mellan tandraderna. Kraften registreras i peak vid maximal sammanbitning under 3 sek och mean av 3 försök görs.
    - Bitkraften som vid "tuggning", mean av 5 försök.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4, 12 and 16 weeks
    4, 12 och 16 veckor
    E.5.2Secondary end point(s)
    - Patient Reported Outcomes assessed by VAS and a swedish version of General Oral Health Assessment Index, GOHAI.
    - Mandibular jaw mowement, measured with SmartEye Pro - MME
    - Patientenkäter och frågeformulär mäts med VAS och en svensk version av GOHAI.
    - Underkäkens rörelsemönster utvärderas med SmartEye Pro - MME.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 12 and 16 weeks.
    4, 12 och 16 veckor.
    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 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 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 Yes
    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 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
    End of study is defined as "the last visit of the last subject undergoing the clinical study".
    Studien är definierad som klar när "sista patienten har genomgått den kliniska studien"
    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 months12
    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: 16
    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 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 state16
    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)
    Patients randomised to control conditions offers botulinum toxin post trial.
    Studiepatienter som randomiseras till kontroll grupp erbjuds botulinum toxin efter studiens avslut.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 02:23:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA