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    Summary
    EudraCT Number:2006-005342-36
    Sponsor's Protocol Code Number:MRZ 60201-0609/1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-005342-36
    A.3Full title of the trial
    A prospective, open-label, multicenter, repeat-dose trial to investigate the safety and efficacy of NT 201, free of complexing proteins, in the treatment of glabellar frown lines
    A.4.1Sponsor's protocol code numberMRZ 60201-0609/1
    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 SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    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 Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameXeomin
    D.3.2Product code NT 201
    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.3.9.2Current sponsor codeNT 101
    D.3.9.3Other descriptive nameClostridium Botulinum Neurotoxin Type A (150 kD) free of complexing proteins
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 glabellar frown lines
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052609
    E.1.2Term Glabellar frown lines
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to investigate the safety and efficacy of NT 201 in repeat dose treatment for the treatment of glabellar frown lines. Subsequent cycles of treatment will be administered to the patient. As many treatment cycles as appropriate (eight at a maximum for patients from studies MRZ 60201-0527/1 and MRZ 60201-0520/1, and two at a maximum for patients from studies MRZ 60201-0724/1 and MRZ 60201-0741/1) according to the wish of the patient and the criterion for repeat dose injections assessed by the investigator may be administered until the study ends.
    The study will investigate endpoints of safety including immunogenicity as well as efficacy endpoints.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale [FWS]) as assessed by the investigator according to FWS
    · Completion of one study in this program (e.g. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1) within 45 days before Screening
    · Stable medical condition
    · Good patient compliance in previous study
    · Age 18 or over
    · Willing and able to complete at least 12 months (patients enrolled from studies MRZ 60201-0520/1, MRZ 60201-0527/1) or 6 months and up to 2 cycles (patients from studies MRZ 60201-0724/1, MRZ 60201-0741/1) of the trial and to comply with trial instructions
    · Written Informed Consent

    · Relapse to moderate or severe glabellar frown lines at maximum frown on FWS as assessed by the investigator
    · Lack of any condition or situation that in the investigator’s opinion may put the patient at significant risk or may interfere significantly with the patient’s participation in the trial
    E.4Principal exclusion criteria
    · Previous treatment with Botulinum toxin of any serotype within the last 12 months in the glabellar area (except for those administered during the previous study)
    · Previous treatment with biodegradable fillers in the glabellar area within the last 12 months
    · Any previous insertion of permanent material in the glabellar area (irregardless of the time between previous treatment and this study)
    · Previous treatment with any facial procedure in the glabellar area within the last 12 months
    · Planned treatment with Botulinum toxin of any serotype in any body region during the study period
    · Any other planned facial aesthetic procedure in the glabellar area during the trial period
    · Inability to substantially lessen glabellar frown lines even by physically spreading them apart
    · Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercilli muscles or a combination of these, or scars in the glabellar area
    · Marked facial asymmetry or ptosis of eyelid and/or eyebrow
    · Any infection in the area of the injection sites
    · Any medical condition that may put the patient at increased risk with exposure to NT 201, including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function
    · History of facial nerve palsy
    · Bleeding disorders
    · Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function (e.g. D-penicillamine, curarine-type muscle relaxants, succinylcholine) or that might interfere with the action of Botulinum toxin (e.g. chloroquine)
    · Evidence of recent alcohol or drug abuse
    · Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with trial results
    · Known allergy or sensitivity to the trial medication or its components
    · Participation in another clinical trial between completion of former study in this program and screening
    · Any condition or situation that in the investigator’s opinion may put the patient at significant risk, may confound the trial results, or may interfere significantly with the patient’s participation in the trial
    · Nursing activity or pregnancy, verified by a positive pregnancy test 1, or planning of a pregnancy during the trial period
    · Childbearing potential with no use of an adequate birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomised partner, abstinence 2 )
    · Employees or direct relatives of an employee of the CROs, the study center or the sponsor
    · Previous participation in this clinical study
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    · Incidence of Adverse Events [AEs]
    · Incidence of AE of special interest [AESI]
    · Clinical biochemistry and hematology at Screening and at Trial Termination and at least every 12 months for completers of studies MRZ 60201-0520/1 and MRZ 60201-0527/1
    · Botulinum type A antibody tests (Fluorescent Immunoassay [FIA-AB] and, if positive, subsequent Hemidiaphragma Assay [HDA]) at Screening and 30 days after treatment
    · Vital signs (pulse rate, blood pressure) at all visits
    · Physical examination at Screening and Trial Termination and at least every 12 months
    for completers of studies MRZ 60201-0520/1 and MRZ 60201-0527/1
    · Concomitant medications at all visits
    · Concomitant treatments at all visits

    Efficacy:
    · Percentage of responders at maximum frown (defined as score ‘none’ or ‘mild’) at each visit as assessed by the investigator according to FWS
    · Percentage of responders at rest at each visit as assessed by the investigator according to FWS
    · Percentage of responders at maximum frown and at rest at each visit by patient’s assessment on 4-point scale
    · Percentage of responders at maximum frown and at rest at each visit by patient’s assessment on 6-point Likert type scale
    · Time to onset of treatment effect
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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.8.4.1Number of sites anticipated in Member State concerned10
    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 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 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
    please refer to protocol chapter 9.1
    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
    E.8.9.2In all countries concerned by the trial years2
    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) 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 Yes
    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 2007-03-21. Yes
    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 state255
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 880
    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 Decision2007-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-28
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