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    Summary
    EudraCT Number:2006-006449-14
    Sponsor's Protocol Code Number:MedAff-BTX-0616
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-006449-14
    A.3Full title of the trial
    A study to compare the efficacy and safety of two different types of Botulinum Toxin Type A (BOTOX or Dysport) in the Treatment of Moderate to Severe Cervical Dystonia
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberMedAff-BTX-0616
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorALLERGAN
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name BOTOX*IM 1FL 100UI
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.8INN - Proposed INNBotulinum toxin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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*SC IM 2FL 500U
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.8INN - Proposed INNBotulinum toxin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    treatment of idiopathic cervical dystonia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048315
    E.1.2Term Cervical spasm
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety and efficacy of fixed dosages of BOTOX or Dysport in the treatment of idiopathic cervical dystonia in subjects who have been previously treated successfully with equivalent doses of BOTOX
    E.2.2Secondary objectives of the trial
    ND
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Subjects with idiopathic cervical dystonia of the predominantly rotational form (i.e., spasmodic torticollis) of minimum duration eighteen (18) months.
    2.Moderate-to-severe symptoms as defined by a minimum Toronto Western Spasmodic Torticollis Scale (TWSTRS) severity scale score of 15, with a rotation score of major or equal to 2 and a duration factor of major or equal to 2.
    3.Subjects have received successful treatment as determined clinically by both the investigator and patient with 180 – 220 U BOTOX in each of the last two (2) treatment sessions.
    4.Cervical dystonia symptom severity is considered predictable and successfully responsive to BOTOX treatment.
    5.The most recent treatment with BOTOX occurred on a date at least 16 weeks prior to study entry, and the subject has received two (2) treatment sessions within the prior 40 weeks with a good clinical response.
    6.Outpatient, male or female subjects, of any race, between 18 and 75 years of age.
    7.Normal screening laboratory values and negative urine pregnancy test (if applicable).
    E.4Principal exclusion criteria
    1. Symptomatic or non-idiopathic cervical dystonia.
    2. Current or previous surgery, peripheral denervation, and/or spinal cord stimulation for the management of cervical dystonia.
    3. Previous injections of phenol or alcohol for cervical dystonia.
    4. History or evidence of secondary non-response to botulinum toxin type A therapy.
    5. Presence of significant anterocollis, retrocollis, or head shift as the principal component of cervical dystonia.
    6. Profound atrophy of the muscles or infection or skin problem in the target area(s) of injection.
    7. Any other disease that might interfere with neuromuscular function or any uncontrolled systemic disease
    8. Current anticoagulant therapy.
    9. Failure to meet prohibited/restricted concomitant medication criteria.
    10. Subjects planning inpatient surgery or other elective hospitalization during the study period.
    11. Females who are pregnant, nursing, or planning a pregnancy (positive urine pregnancy test) or females of childbearing potential, not using a reliable means of contraception.
    12. History of treatment with botulinum toxin type A or B of any brand other than BOTOX within the past two (2) years.
    13. Allergy or sensitivity to any component of the study medication.
    14. Recent history of alcohol or drug abuse (as defined by DSM IV criteria).
    15. History of poor cooperation, non-compliance with medical treatment, or unreliability.
    16. Subjects currently participating in another investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit unless approved by the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Evaluation:
    Spontaneous Adverse Event Query
    Subjects will be asked “Have you experienced any change in your health since the last study visit?” to elicit spontaneous reports of adverse events.
    Structured Symptom Interview
    After completing the documentation of spontaneous adverse events, subjects will be given a Structured Symptom Interview (SSI). Any positive reply will require the subject to grade the severity on a 0 to 10 scale. For any evaluation in which the severity grade is at least 2 points higher than the rating at baseline, the adverse event must also be recorded on an adverse event case report form. The Structured Symptom Interview will be administered at every visit through week 10.
    Dystonia Study Group Dysphagia Interview (DSGDI)
    All subjects will be asked to complete a detailed Dysphagia Interview (DSGDI). The DSGI will be administered for patients at every visit through Week 10.
    Efficacy Evaluation:
    A) PHYSICIAN EVALUATED EFFICACY VARIABLES
    Physician Assessment of Cervical Dystonia Severity and Toronto Western Spasmodic Torticollis Scale (TWSTRS):: The PHYSICIAN ASSESSMENT OF CERVICAL DYSTONIA SEVERITY and TWSTRS will be conducted at each study visit.
    Global Assessment of Benefit by Physician: At week 2 and all subsequent visits, the physician will evaluate the subject’s benefit from botulinum toxin type A treatment for cervical dystonia using the GLOBAL ASSESSMENT OF BENEFIT BY PHYSICIAN.
    Comparison of Benefit to Previous Injection: At week 4 and 10, the physician will evaluate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to previous treatment.
    B) PATIENT REPORTED EFFICACY OUTCOME
    Global Assessment of Benefit by Patient: At week 2 and all subsequent visits, the subjects will rate the benefit from botulinum toxin type A treatment for cervical dystonia using the GLOBAL ASSESSMENT OF BENEFIT BY PATIENT.
    Patient Analog Assessment of Pain: At each study visit, subjects will be queried regarding their assessment of pain using a Visual Analog Scale rating the pain from “no pain” to “worst possible pain” .
    Comparison of Benefit to Previous Injection: At week 4 and at the exit visit, subjects will be queried regarding their evaluation of benefit of the current treatment of their cervical dystonia with botulinum toxin type A compared to previous treatment.
    Patient Assessment for Retreatment: At each study visit, subjects will be queried regarding their need for another injection of botulinum toxin type A for cervical dystonia.
    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 Information not present in EudraCT
    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 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) Information not present in EudraCT
    E.8.2.2Placebo No
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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.1.3Elderly (>=65 years) Yes
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 160
    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 Decision2007-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-23
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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