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    Summary
    EudraCT Number:2019-003503-35
    Sponsor's Protocol Code Number:PAINTX
    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:2019-12-02
    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 number2019-003503-35
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Effect of Botulinum Toxin A on Patients with Atypical Odontalgia/Persistent Dentoalveolar Pain.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studies of the treatment effect of botulinum toxin A on patients with neurogenic pain in the mouth
    A.4.1Sponsor's protocol code numberPAINTX
    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 SponsorRegion Östergötland
    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, Region Östergötland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Östergötland
    B.5.2Functional name of contact pointAndreas Dawson
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Oral Rehabilitation, Torkelbergsgatan 11
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58185
    B.5.3.4CountrySweden
    B.5.6E-mailandreas.dawson@regionostergotland.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 Dysport
    D.2.1.1.2Name of the Marketing Authorisation holderInstitut Produits Synthèse (IPSEN) AB
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGingival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum toxin type A - haemagglutinin complex
    D.3.9.1CAS number Not known
    D.3.9.3Other descriptive nameBotulinum toxin type 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.3.10.3Concentration number300
    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 placeboGingival use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atypical Odontalgia/Persistent Dentoalveolar Pain
    E.1.1.1Medical condition in easily understood language
    Neurogenic pain in the mouth
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    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
    To investigate the treatment outcome of botulinum toxin A compared to placebo (saline) on PDAP/AO patient pain assessment using NRS, measured at baseline and 24 weeks after the first BTX-A injection.
    E.2.2Secondary objectives of the trial
    Secondary aims are to evaluate the treatment outcome of botulinum toxin A for treatment of PDAP/AO on
    (1) Pain related variables, evaluated with NRS, MPQ, PDRAW and by patient pain medication use;
    (2) Physical functioning, evaluated with GCPS, JFLS-20, OHIP-S14;
    (3) Emotional functioning, evaluated with PHQ-9, GAD-7, PHQ-15, PSS-10, PCS, and ISI;
    (4) Somatosensory abnormalities, evaluated with QualST;
    (5) Evaluate the safety of using botulinum toxin A for treatment of PDAP/AO by evaluation of frequencies of adverse events.
    (6) Patient assessed general improvement evaluated with PGIC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •´A diagnosis of PDAP/AO with all of the following four criteria fulfilled:
    1) Persistent pain (pain at least 8 h per day, at least >15 days per month for >3 months) localized in the dento-alveolar region
    2) Pain onset is in close temporal relation to a causal event (e.g. dental procedures, facial trauma)
    3) Somatosensory abnormalities are present in the painful area.
    4) Not caused by another disease or disorder
    • Daily pain for at least 6 months (according to patient report)
    • Average pain intensity of > 5 on a numeric rating scale.
    • >18 years of age
    • For women of child-bearing potential:
    a negative highly sensitive urine pregnancy test, and
    agree to use an effective method of contraception (progestogen-only hormonal contraception, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) as a minimum used until treatment discontinuation.
    E.4Principal exclusion criteria
    • inflammatory tooth pain, trigeminal neuralgia, trigeminal autonomic cephalalgias, myasthenia gravis, amyotrophic lateral sclerosis,
    • known hypersensitivity for botulinum toxin A
    • Inflammation in the site of injection
    • Pregnancy or nursing,
    • History of drug or alcohol abuse,
    • coagulation disorders
    • previous use of BTX-A in the orofacial region during the last 6 months
    • use of drugs that exerts its effect on neuromuscular junctions or coagulation disorders
    • major psychiatric disorders.
    E.5 End points
    E.5.1Primary end point(s)
    Patient pain assessment using the NRS scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 24 weeks after the first BTX-A injection
    E.5.2Secondary end point(s)
    Secondary end points and methods for evaluation are listed together with the secondary objectivs of the trial in section E.2.2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and 12 weeks, 24 weeks and 1 year after the first BTX-A injection
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    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 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state37
    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
    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 Decision2020-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-30
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