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    Summary
    EudraCT Number:2018-001703-37
    Sponsor's Protocol Code Number:D-FR-52120-244
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001703-37
    A.3Full title of the trial
    A double-blind, randomised, placebo controlled, proof-of-concept study in subjects with abdominal or thoracic chronic scar pain to assess the analgesic properties of intradermal doses of Dysport®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dysport in Post-Surgical Neuralgia (RESPITE)
    A.3.2Name or abbreviated title of the trial where available
    Dysport in Post-Surgical Neuralgia (RESPITE)
    A.4.1Sponsor's protocol code numberD-FR-52120-244
    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 SponsorIpsen Innovation SAS
    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 supportIpsen Innovation SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Pancras Clinical Research
    B.5.2Functional name of contact pointDr Stuart Ratcliffe
    B.5.3 Address:
    B.5.3.1Street Address285-287 Gray's Inn Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1X 8QD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02038651142
    B.5.5Fax number02078377707
    B.5.6E-mailstuartratcliffe@stpancrasclinical.com
    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 holderIPSEN Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClostridium botulinum type A toxin-haemagglutin complex
    D.3.9.1CAS number 953397-35-8
    D.3.9.3Other descriptive nameDysport
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-Surgical neuralgia
    E.1.1.1Medical condition in easily understood language
    Chronic scar-related pain after surgery
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to describe the pharmacodynamic analgesic profile (time of onset of meaningful analgesic effect, peak-effect, time to peak-effect, duration of effect) of intradermal doses of Dysport in subjects with abdominal or thoracic chronic scar pain.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the efficacy of intradermal doses of Dysport to placebo, and to assess the safety and tolerability of a range of intradermal doses of Dysport.

    In addition, exploratory objectives are to explore improvement of quality of life (QoL) using SF-36 questionnaire, and assess the concomitant use of rescue medication (analgesia).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be considered eligible for enrolment in the study, subjects must fulfil all of the following criteria:
    1) Male and female subjects aged between 18 and 80 years inclusive at the time of giving informed consent.
    2) Subjects suffering from an area of chronic pain post-abdominal or thoracic surgery, chronic abdominal or thoracic scar pain
    3) Longitudinal axis of the pain area of 10 cm long maximum (as mapped upon screening).
    4) Subjects with moderate to severe pain, i.e. spontaneous NRS score of 4-8 stable for the previous month before screening.
    5) Stable use of analgesics (or any medication impacting pain perception) during the month before screening and expected to be stable for the study duration.
    6) Time from surgery which caused the painful scar more than six months and less than five years at screening.
    7) No other distracting pain either chronic or acute.
    8) Female subjects of childbearing potential must have a negative urine pregnancy test result and be willing to use reliable contraceptive measures throughout study participation. Reliable forms of contraception include but are not limited to hormonal contraceptives (e.g. oral, patch, injection), double-barrier (e.g. male condom plus spermicide, or female diaphragm plus spermicide), intrauterine device, male partner has had a vasectomy, total abstinence from intercourse with male partners (periodic abstinence is not acceptable). Female subjects meeting any of the following criteria are not considered to be of childbearing potential: postmenopausal (≥ 47 years of age and amenorrhoeic for at least 12 consecutive months), have been sterilised surgically (e.g. bilateral tubal ligation), have had a hysterectomy, have had a bilateral oophorectomy.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will not be considered eligible for enrolment in the study.
    1) Previous treatment with BTX (any serotype) during the past six months before screening.
    2) History of hypersensitivity to any of the components of the Dysport formulation (which includes human serum albumin and lactose) or allergy to cow's milk protein.
    3) Known hypersensitivity to lidocaine or other anaesthetics of the amide type, known hypersensitivity to hydroxybenzoates, complete heart block, hypovolaemia.
    4) Any medical condition that may put the subject at risk with exposure to BTX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
    5) Neuroma in the scar pain area, diagnosed per ultrasound.
    6) Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine.
    7) Need of any prohibited medication.
    8) Any abnormal laboratory value, physical examination, vital signs, or electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant and that would compromise the safety of the subject in the study.
    9) Positive for hepatitis B antigen or hepatitis C virus ribonucleic acid, positive results for human immunodeficiency virus, or who receives diagnosis for acquired immunodeficiency syndrome.
    10) Positive urine screen for drugs of abuse (except for cotinine and unless explained by the investigator for therapeutic use of medication) or any history of drug or alcohol abuse, misuse, physical or psychological dependence, mood changes, sleep disturbance and functional capacity which have an impact on pain perception.
    11) Significant neurological or psychiatric disorders including mental instability (unrelated to the pain) that could interfere with pain assessments; other pre-existing pain syndromes, acute or chronic, that might impair the assessment of the scar pain.
    12) Any medical history of significance and/or inadequately controlled such as cardiovascular (e.g. uncontrolled high blood pressure, high risk of cardiovascular events, severe heart failure), pulmonary (e.g. uncontrolled asthma or emphysema), heamatologic, (e.g. coagulopathy/bleeding disorders), neurological (e.g. swallowing problems, blurred or double vision, trouble saying words clearly (dysarthria), hoarseness or change or loss of voice (dysphonia)), liver disease (e.g. severe hepatic impairment), kidney disease (e.g. impaired renal function in subjects taking diuretics, angiotensin converting enzyme (ACE)-inhibitors, or angiotensin II antagonists), endocrine, immunologic, dermatologic painful conditions or any other conditions that may compromise in the opinion of the investigator the ability of the subject to participate in the study.
    13) If in the investigator’s opinion there are any factors that may confound the analysis of the study regarding efficacy and safety (e.g. an NRS > 9).
    14) The subject’s primary care physician has provided evidence which can be used to confirm that within the last 12 months of dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study.
    15) Previous randomisation in this study.
    16) Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days before screening.
    17) Subjects who are incapable of complying with the protocol in the judgment of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is describe the pharmacodynamic analgesic profile (time of onset of meaningful analgesic effect, peak-effect, time to peak-effect, duration of effect) of intradermal doses of Dysport in subjects with abdominal or thoracic chronic scar pain. Therefore, the primary outcome measure is a composite of the following, based upon the Numerical Rating Scores (NRS) as recorded by the patients:
    • Time to onset, i.e. time to decrease from baseline of two points in the spontaneous NRS score,
    • Peak-effect, i.e. maximal decrease from baseline in the spontaneous NRS score,
    • Time to peak-effect, i.e. time to reach the peak-effect,
    • Duration of effect, i.e. duration between time to onset and last timepoint with change from baseline in the spontaneous NRS score is ≥ two points,
    • Change from baseline in the spontaneous NRS score to each scheduled timepoint,
    • Change from baseline in the stimulus-evoked NRS score to each scheduled timepoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The subjects will be assessed for up to 16 weeks post-dosing of Dysport or placebo.
    E.5.2Secondary end point(s)
    The secondary and exploratory endpoints are:

    Secondary
    • To compare the efficacy of intradermal doses of Dysport to placebo.
    • To assess the safety and tolerability of a range of intradermal doses of Dysport.
    Exploratory
    • To explore improvement of quality of life (QoL) using SF-36 questionnaire.
    • To explore concomitant use of rescue medication (analgesia).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The subjects will be assessed for up to 16 weeks post-dosing of Dysport or placebo.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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.8.4.1Number 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
    Last patient last visit.
    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 months6
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Although this is a Phase 2 study, if subjects completing Part B experience significant improvement in pain control we will inform the subjects GP in advance of completion of study treatment, and instruct the subject to arrange an appointment with their GP to receive Standard of Care Treatment which may include off-label Dysport. We will stress then 'off-label' aspect so as not to raise expectations unnecessarily.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-08
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