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    Summary
    EudraCT Number:2011-004636-66
    Sponsor's Protocol Code Number:KP-2011-0077
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-06
    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 number2011-004636-66
    A.3Full title of the trial
    Single-blinded randomized trial of Botulinumtoxin A (Vistabel®) and its objective paralytic effect in the facial muscles of healthy women: development of new neurophysiological measurements.
    Enkelblind randomiserad studie av botolinumtoxin A (Vistabel®) och dess objektiva paralytiska effekt i ansiktsmuskler hos friska kvinnor: utveckling av nya neurofysiologiska effektmått.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Development of a method for the measuremnet of botulinumtoxin injection in the facial muscles
    Utveckling av en metod att mäta effekten av botulinumtoxininjektioner i ansiktsmuskulatur
    A.3.2Name or abbreviated title of the trial where available
    Glabellar neurophysiology upon BoNT injection
    A.4.1Sponsor's protocol code numberKP-2011-0077
    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 SponsorUppsala University Hospital
    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 supportBaau Therapeutics AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala University Hospital
    B.5.2Functional name of contact pointDepartment of Clinical Neurophysiol
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Clinical Neurophysiology, Uppsala University Hospital, UAS, entrance 85, 3rd floor
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46186113441
    B.5.6E-mailsekretariat.neurofys@akademiska.se
    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 VISTABEL
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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.3.4Pharmaceutical form 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.3.9.1CAS 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 unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 VISTABEL
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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.3.4Pharmaceutical form 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.3.9.1CAS 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 unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    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 VISTABEL
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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.3.4Pharmaceutical form 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.3.9.1CAS 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 unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    The treatment of glabellar lines in healthy women by muscle paralysis from injection of botulinum toxin
    Behandling av “arghetsrynkor” hos friska kvinnor genom muskelparalys med botulinum toxin.
    E.1.1.1Medical condition in easily understood language
    The muscle paralyzing effect of botolinum toxin in the application of facial wrinkles.
    Botolinumtoxinets muskelparalyserande effekt på ansiktsrynkor.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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 reduction of the muscle response (muscle paralysis) by motor nerve stimulation (“CMAP”) from the facial muscles correlates with the given dose botulinum toxin (Vistabel in Allergan units) injected in the muscle.
    Reduktionen av det sammansatta motoriska svaret vid neurografi (s.k. CMAP) över glabellarmuskulaturen korrelerar med dosen botulinumtoxin typA (Vistabel, angivet som Allerganenheter) som injicerats i muskeln.
    E.2.2Secondary objectives of the trial
    The distance effect to other facial muscles by botulinum toxin injection in the glabellar muscles is a good measure of the ”safety” of injection and correlates to the given botulinum toxin dose.
    Distanseffekten till andra ansiktsmuskler (ögonmusklerna) av botulinumtoxininjektion i glabellarmusklerna beskriver ”säkerheten” av injektionen och korrelerar mot given dos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy women in the age of 30-64 years of age (not yet 65 years). Visible glabellar lines. Motivated to participate in the clinical trial without any economical compensation. Filled in the informed consent.
    Friska kvinnor i åldersintervallet 30-64 år (ej fyllda 65 år).Synliga glabellaveck ("arghetsrynka"). Motiverade att delta i studien utan ekonomisk kompensation. Ifylld informerat samtycke.
    E.4Principal exclusion criteria
    Clinical or subclinical neuromuscular disorder/symptoms. Allergy towards the BoNT which will be used or other component. Previous injections of BoNT or plastic surgery in the facial region. Implants in the glabellar region. Ongoing infection, systemic disease or inflammation around the muscles to be injected. Earlier unspecified severe allergic reactions. Known coagulation deficit or anticoagulantia. Medication with anticholinergic or muscle relaxing agents. Pregnancy or lactation.
    Känd eller subklinisk neuromuskulär sjukdom. Allergi mot det BoNTs som används eller annan ingående komponent. Tidigare BoNT-injektioner eller plastkirurgisk åtgärd i ansiktet. Förekomst av implantat i anslutning till glabellaområdet. Pågående infektion, systemisk sjukdom eller inflammation kring injektionslokaler. Tidigare ospecifika svåra allergiska sjukdomar. Känd koagulationsrubbning eller antikoagulantia. Aktuell medicinering med läkemedel med antikolinergisk eller muskelavslappnande effekt. Graviditet eller amning.
    E.5 End points
    E.5.1Primary end point(s)
    Course of muscle paralysis, denervation and reinnervation from BoNT injection in facial muscles.
    Förloppet av muskelförlamning, denervation och reinnervation följande BoNT injektion i ansiktsmuskler.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time points include: 1) Before BoNT injection (baseline) 2) 2 weeks following BoNT 3) 4 weeks following BoNT 4) 12 weeks following BoNT 5) 24 weeks following BoNT
    Tidpunkter: 1) Före BoNT injection (baslinjenivå) 2) 2 veckor efter BoNT 3) 4 veckor efter BoNT 4) 12 veckor efter BoNT 5) 24 veckor efter BoNT
    E.5.2Secondary end point(s)
    Course of distance effects to surrounding facial muscles (eye muscles) following glabellar BoNT injection.
    Förloppet av distanseffekter till omgivande ansiktsmuskler (ögonmuskler) efter injection av BoNT i ansiktets glabellarmuskler.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time points include: 1) Before BoNT injection (baseline) 2) 2 weeks following BoNT 3) 4 weeks following BoNT 4) 12 weeks following BoNT 5) 24 weeks following BoNT
    Tidpunkter: 1) Före BoNT injection (baslinjenivå) 2) 2 veckor efter BoNT 3) 4 veckor efter BoNT 4) 12 veckor efter BoNT 5) 24 veckor efter BoNT
    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
    Development of new neurophysiological measures that objectively correlates with the therapeutic effect as well as distance effects of facial muscle BoNT injection.
    Utveckling av nya neurofysiologiska effektmått för att detaljerat och objektivt mäta effekten av botulinumtoxininjektion i ansiktsmuskulatur
    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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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 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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-10-06. Yes
    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)
    No planned care or follow-up after the last visit (24 weeks).
    Ingen ytterligare vård eller uppföljning är planerad efter sista besöket (24 veckor).
    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 Decision2011-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-10
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