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    Summary
    EudraCT Number:2004-001845-13
    Sponsor's Protocol Code Number:Y-47-52120-722
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-03
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-001845-13
    A.3Full title of the trial
    A phase II, multicentre, multinational, prospective, randomised, double-blind, placebo controlled study assessing the efficacy and safety of a single application of three doses of Dysport in patients with upper back myofascial pain syndrome (MPS)
    A.4.1Sponsor's protocol code numberY-47-52120-722
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBeaufour Ipsen Pharma S.A.S.
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Dysport
    D.2.1.1.2Name of the Marketing Authorisation holderBeaufour Ipsen International
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameDysport
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameClostridium botulinum type A toxin haemagglutinin complex
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeToxin
    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 placeboPowder 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
    Upper back myofascial pain syndrome (MPS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10048780
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of a single application of Dysport (100, 300 or 500 units) injected into 3 to 6 trigger points (TPs) located in the upper back musculature of adults with (MPS) with placebo
    E.2.2Secondary objectives of the trial
    To assess the safety profile of each of the doses of Dysport
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The patient must present at baseline with pain score of moderate or severe on a 4-point rating scale. Pain score is an overall rating of pain experienced during activity over the 7 days prior to the visit.

    The patient must have suffered from upper back, myofascial pain syndrome for more than 6 months.

    The patient must present with at least 3 active TrPs in the region of the upper back musculature (excluding upper neck musculature). An active TrP is defined as a tender spot localised in a taut band of muscle fibres associated with tenderness and referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation and, preferably local twitch response at palpation and/or jump sign at palpation (derived from Travell and Simons).

    The patients’ pain medication regimen must be stable and within the normal recommended doses on study entry and must remain so until Week 6.

    The patient must be aged 18 years or older.

    The patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient.
    E.4Principal exclusion criteria
    The patient suffers from pericranial or upper neck pain, or specific shoulder pain, such as tumours, radicular syndromes, inflammatory processes, age-untypical degenerative changes, infection, clinically manifest prolapse, neurological failure, chronic polyarthritis, collagenosis, Bechterew's disease, disc herniation, nerve root impingement or fibromyalgia.

    The patient has suffered from upper back MPS for more than 24 months.

    The patient has received surgery on the cervical spine in the last 6 months.

    The patient has any mental condition which results in him/her being unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.

    The patient has received anaesthetic injections to the TrP’s within 1 month prior to study entry.

    The patient has received steroid injections for their MPS in the last 3 months.

    The patient has a known history of non-responsiveness to botulinum toxin A or has received botulinum toxin A in the last 6 months.

    The patient has a known history of hypersensitivity to the investigational drug, its constituents or drugs with a similar mechanism of action.

    The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol.

    The patient has hypertension that is not adequately controlled by treatment.

    The patient has a history of other muscular diseases or diseases of neuromuscular transmission e.g. myasthenia gravis.

    The patient has a history of, or current problems with alcohol/drug abuse and/or analgesic overuse/abuse.

    The patient is pregnant or lactating. Females of childbearing potential must provide a negative pregnancy test within 7 days prior to the start of the study and must be using oral or injectable contraception. (Non-childbearing potential is defined as post menopausal for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study).

    The patient has received any other investigational drug within the 30 days prior to study entry.

    The patient has abnormal baseline findings considered by the investigator to indicate conditions that might affect the study.

    The patient has any other condition that, in the opinion of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in pain score for ‘overall pain of the day during activity’ between baseline and week 6. This pain score is the mean of the individual pain scores recorded each day (evenings) for the 7 days prior to each visit assessed using an 11-point numerical rating scale with the following question, ‘overall pain of the day during activity’.
    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 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 Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    The end of the trial is defined as the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 2005-03-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 340
    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 Decision2004-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-05-18
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