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    Summary
    EudraCT Number:2021-002784-21
    Sponsor's Protocol Code Number:20210516
    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:2022-02-09
    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 number2021-002784-21
    A.3Full title of the trial
    Botulinum toxin type A as treatment for chronic myogenous orofacial pain - a radomized controlled, double-blind clinical trial
    Botulinumtoxin A som behandling vid långvarig orofacial smärta – en randomiserad och kontrollerad dubbelblindad studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Botulinum toxin type A as treatment for chronic facial muscle pain.
    Botulinumtoxin A som behandling mot långvarig käkmuskelsmärta.
    A.4.1Sponsor's protocol code number20210516
    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 SponsorVästra Götalandsregionen
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska Academy at the University of Gotheburg
    B.5.2Functional name of contact pointInstitute of odontology
    B.5.3 Address:
    B.5.3.1Street AddressMedicinaregatan 12E
    B.5.3.2Town/ cityGothenburg
    B.5.3.4CountrySweden
    B.5.4Telephone number+46317860000
    B.5.6E-mailinfo@odontologi.gu.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 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 Powder for 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 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
    Chronic myalgia (>6months) in the facial region.
    E.1.1.1Medical condition in easily understood language
    Chronic muscle pain (>6months) in the facial region.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    Evaluate whether botulinum toxin A provides a significantly better pain-relieving effect for patients with orofacial myalgia compared to saline up to 6 months via evaluation of subjective perception of pain reduction and number of millimeters of pain free mouth opening.
    Utvärdera om botulinumtoxin A ger en signifikant bättre smärtlindrande effekt hos patienter med orofacial myalgi jämfört med koksalt upp till 6 månader. Detta kontrolleras via subjektiv uppfattning av smärtreduktion och antal millimeter smärtfri gapförmåga.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to
    1) evaluate if pain reduction is correlated to psychosocial factors
    2) evalute the time aspect of any possible pain reduction in patients that have received Botox 6 months after final injection.
    II) att utvärdera om graden av smärtlindring kan relateras till psykosociala faktorer.
    III) att följa tidsaspekt på eventuell kvarstående smärtlindring efter botulinumtoxin A 6 månader efter sista injektion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age at least 18years
    Written consent
    Adequate communicative skills in Swedish
    Myalgia as defined by DC/TMD
    Prior conservative treatment for at least 6months with a minimum of information on diagnosis and prognosis, patient councelling, instruction in resting the jaw, biofeedback training and jaw exercise
    Subjective degree of pain ≥ 40mm on a 100mm VAS scale
    Ålder ≥18år
    Skriftligt medgivande
    Förstå svenska i tal och skrift
    Diagnos myalgi i käkmuskulatur enligt DC/TMD
    Erhållit konservativ behandling omfattande minst information om diagnos och prognos, lugnande samtal, instruktion i käkens viloläge, biofeedbackträning med EMG samt rörelseträning
    VAS ≥ 40mm på en 100mm skala vid urvalsbesök
    E.4Principal exclusion criteria
    Pain of dental origin
    Athritis as defined by DC/TMD expanded taxonomy
    Rheumatic disease diagnosed by physician (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis / Bechterew's disease, reactive arthritis, juvenile idiopathic arthritis)
    Neuropathic pain, diagnosed by physician, of central / peripheral genesis or infectious / inflammatory genesis (eg stroke, multiple sclerosis, brain damage, traumatic or surgically triggered facial injury, tumor-induced nerve involvement, postherpetic neuralgia, trigeminal neuralgia, neuroborreliosis
    Impaired neuromuscular transmission e.g. myasthenia gravis or Eaton Lambert's syndrome or peripheral motor neuropathic and neurological diseases (eg amyotrophic lateral sclerosis or motor neuropathy), diagnosed by physician
    Hypersensitivety or allergy to any botulinum toxin product or to any of the components in the formulation

    Pregnancy / breastfeeding or planned pregnancy. Women of childbearing potential must use highly effective contraceptives i.e oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception, oral, injectable or implantablie progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS) 2, bilateral tubal occlusion, vasectomised partner. CE- approved pregnancy tests are handed to the patient for monthly tests up to 6 months after the last injection (a total of 11 tests).
    Infection at site of injection
    Ongoing treatment with aminoglycosides, cholinesterase inhibitors or muscle relaxants
    Prior or ongoing treatment with botulinum toxin A of any serotype
    • Dentalt relaterad smärta
    • Käkledsartrit enligt DC/TMD expanded taxonomy
    • Av läkare diagnosticerad reumatisk sjukdom (reumatoid artrit, psoriasisartrit, ankyloserande spondylit/ Bechterews sjukdom, reaktiv artrit, juvenil idiopatisk artrit)
    • Av läkare diagnosticerad neuropatisk smärta av central/perifer genes eller infektiös/inflammatorisk genes (t.ex. stroke, multipel skleros, hjärnskada, traumatiskt eller kirurgiskt utlöst skada i ansikte, tumörorsakad nervpåverkan, postherpetisk neuralgi, trigeminusneuralgi, neuroborrelios)
    • Av läkare bedömd nedsatt neuromuskulär transmission t.ex. myasthenia gravis eller Eaton Lamberts syndrom
    Av läkare diagnosticerade perifera motoriska neuropatiska och neurologiska sjukdomar (t.ex. amyotrofisk lateral skleros eller motorisk neuropati).
    • Allergi mot komponent i Allergan Botox
    • Graviditet/amning eller planerad graviditet. Kvinnor i fertil ålder skall använda högeffektiva antikonceptionsmedel (sterilisering, steriliserad partner, kombinationsmedel östrogen och gestagen i form av p-piller, p-plåster och p-ring, hormonella medel innehållande gestagen i form av p-piller, p-plåster, p-spruta, p-ring, p-stav, hormonspiral eller kopparspiral) CE-märkta, godkända graviditetstest lämnas ut i samband med urvalsbesök och för månatliga test t.om 6 månader efter sista injektion (totalt 11 test).
    • Pågående medicinering med aminoglykosider, kolinesterashämmare eller muskelavslappnande medel
    • Infektion vid det planerade injektionsstället
    • Tidigare behandling med botulinumtoxin av annan serotyp

    Pågående medicinering med aminoglykosider, kolinesterashämmare och/eller botulinumtoxin oavsett serotyp
    E.5 End points
    E.5.1Primary end point(s)
    30% subjective pain reduction on a VAS scale and at least 40millimeter pain free mouth opening.
    30% subjektiv smärtreduktion på en VAS-skala och minst 40 millimeter smärtfri gapförmåga.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 months, 3 months, 4 months, 6 months and 9 months for all patients.
    1 månader, 3 månader, 4 månader, 6 månader och 9 månader för alla patienter.
    E.5.2Secondary end point(s)
    Evaluate if pain reduction is correlated to psychosocial factors at baseline.
    Utvärdera om smärtreduktion är korrelerat till psykosociala faktorer vid baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 months
    9 månader
    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 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 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 concerned2
    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
    Studiens avslut sker i samband med att sist inkluderade forskningsperson som erhållit behandling med Botox® eller koksalt varit på sin sista kontroll.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state72
    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)
    After ended participation patients who have received saline (placebo) and whose pain has persisted will be offered Botox injections. Patient who have received Botox and whose pain has persisted will go on with conventional treatment.
    Efter det att hela studien är avslutad och alla patienter behandlats enligt randomiseringsförfarande, erbjuds de patienter som fått koksalt och har kvarstående symtom att få behandling med Botox. Patient som har fått Botox och vars smärta har kvarstått kommer att fortsätta med konventionell behandling.
    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 Decision2022-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-18
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