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    Summary
    EudraCT Number:2014-003770-16
    Sponsor's Protocol Code Number:MRZ60201_3100_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:2015-01-22
    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 number2014-003770-16
    A.3Full title of the trial
    A prospective, open-label, multicenter, repeat-dose trial to investigate the safety and efficacy of NT 201 (incobotulinumtoxinA) in the combined treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label study with up to four repeated injections to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face.
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code numberMRZ60201_3100_1
    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 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 supportMerz Pharmaceuticals GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerz Pharmaceuticals GmbH
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressEckenheimer Landstrasse 100
    B.5.3.2Town/ cityFrankfurt/Main
    B.5.3.3Post code60318
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@merz.de
    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 nameNT 201
    D.3.2Product code NT 201
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeNT 101
    D.3.9.3Other descriptive nameBotulinum neurotoxin type A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U 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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines)
    E.1.1.1Medical condition in easily understood language
    Moderate to severe wrinkles in the upper face
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10040954
    E.1.2Term Skin wrinkling
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 safety and tolerability of 54 to 64 Units [U] of NT 201 intramuscularly administered in subjects with moderate to severe upper facial lines [UFL] during repeat-dose treatment of these lines.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of simultaneous treatment of moderate to severe UFL during repeat-dose injection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria
    • Signed written informed consent obtained from subject.
    • Outpatients (male or female) 18 years of age or older.
    • HFL, GFL, and symmetrical LPL of moderate to severe intensity at maximum contraction as assessed by the investigator according to the Merz Aesthetics Scales.
    • Stable medical condition.

    Eligibility criteria for reinjection
    • Subjects must have relapsed to at least moderate intensity at maximum contraction in all three treated areas as assessed by the investigator.
    • Absence of ongoing adverse events related to toxin spread.
    • No infection and/or inflammation in the area of the planned injection points.
    E.4Principal exclusion criteria
    Main exclusion criteria
    • Previous treatment with any facial cosmetic procedure (e.g. dermal filling, chemical peeling, photo rejuvenation) in the forehead, glabellar, and/or periorbital area within the last 8 months before injection.
    • Previous treatment with Botulinum toxin of any serotype in the forehead, glabellar, and/or periorbital area within the last 6 months before injection.
    • Any previous insertion of permanent material in the forehead, glabellar, and/or periorbital area (regardless of the time between previous treatment and this study).
    • Planned treatment with Botulinum toxin of any serotype in the face during the study period.
    • Any other planned facial cosmetic procedure in the face during the study period.
    • Very severe lines (HFL, GFL, and/or LPL) at maximum contraction as assessed by the investigator according to the Merz Aesthetics Scales.
    • Inability to substantially lessen UFL (HFL, GFL, LPL) by physically spreading them apart.
    • Any surgery or scars in the forehead, glabellar, or periorbital area.
    • Marked facial asymmetry.
    • Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
    • Eyelid ptosis.
    • Marked brow ptosis.
    • History of facial nerve palsy.
    • Any infection and/or inflammation at the planned injection points.
    • Bleeding disorders or regular intake of drugs with anticoagulative effect within the last ten days prior to injection until four days after injection.
    • Any medical condition that may put the subject at increased risk with exposure to NT 201, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function.
    • Intake of any of the forbidden concomitant medication, e.g. aminoglycoside antibiotics, or other agents that might interfere with neuromuscular function (e.g. D-penicillinamine, curarine-type muscle relaxants, succinylcholine) or might interfere with the action of BoNT A (e.g. chloroquine) within 14 days prior to injection.
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety variables:
    • Incidence of Treatment Emergent Adverse Events [TEAEs] during the overall period of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    E.5.2Secondary end point(s)
    Secondary safety variables:
    • Incidence of Treatment Emergent Adverse Events [TEAEs] per treatment cycle.
    • Incidence of Treatment Emergent AEs of special interest [TEAESIs] during the overall period of the study and per treatment cycle.

    Secondary efficacy variables:
    • Percentage of responders at maximum contraction for the three treated areas individually at day 30 of each injection cycle as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). The periorbital region/crow’s feet will be assessed separately for each facial side (left and right) and both sides have to respond according to the previous responder definition
    • Percentage of responders at day 30 of each injection cycle for the overall appearance of the upper face, as self-assessed by the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy variables at day 30 of each injection cycle
    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 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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned12
    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
    The end of study is defined as the last visit of the last subject.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state130
    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)
    No specific post-study arrangements are made and no specific post-study care will be performed after this study.
    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 Decision2015-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-08
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