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    Summary
    EudraCT Number:2014-005303-24
    Sponsor's Protocol Code Number:MT10109L-004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-09
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-005303-24
    A.3Full title of the trial
    A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MT10109L in the Long-term, Open-label Treatment of Glabellar Lines and Lateral Canthal Lines
    A.4.1Sponsor's protocol code numberMT10109L-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04157686
    A.5.4Other Identifiers
    Name:INDNumber:121473
    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 SponsorMedytox Inc
    B.1.3.4CountryKorea, Republic of
    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 supportMedytox Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedytox
    B.5.2Functional name of contact pointWansoon Lee
    B.5.3 Address:
    B.5.3.1Street AddressMeytox 78, Gangni 1-gil, Ochang-eup, Cheongwon-gu,
    B.5.3.2Town/ cityChungcheongbuk-do
    B.5.3.3Post code28126
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82269015851
    B.5.6E-maildrlee@medytox.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 No
    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 namenivobotulinumtoxinA
    D.3.2Product code MT10109L
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNNA
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Glabellar Lines & Lateral Canthal Lines
    E.1.1.1Medical condition in easily understood language
    Treatment of Glabellar lines (GL) & Lateral Canthal Lines (LCL) . GL are lines between the eyebrows. LCL or crow’s feet lines [CFL]) are horizontal smile lines by the sides of the eyes.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10052609
    E.1.2Term Glabellar frown lines
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of repeat treatments of MT10109L in participants with moderate to severe GL, LCL, or both (GL and LCL)
    E.2.2Secondary objectives of the trial
    The proportion of participants with none of mild adverse events, a high
    satisfaction rate, and improvement rate from baseline;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Completion of lead-in Phase 3 study: Study MT10109L-001 for GL participants, Study MT10109L-002 for LCL participants, Studies MT10109L-005 or-006 for GL and LCL participants.
    - Stable medical condition, in the opinion of the investigator
    - Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
    - Female participants of childbearing potential must have a negative urine pregnancy test before each study intervention. A female is considered NOT to be of childbearing potential if she is premenarchal, postmenopausal (at least 12 consecutive months without menstruation), or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral oophorectomy).
    - Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
    - Written informed consent from the participant has been obtained prior to any study-related procedures.
    - Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites])
    - Ability to follow study instructions, including completing study assessment tools without any assistance or alteration to the assessment tools and likely to complete all required visits
    E.4Principal exclusion criteria
    - Known immunization or hypersensitivity to any botulinum toxin serotype
    - Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
    - Any brow or eyelid ptosis, as determined by the investigator
    - Infection or skin disorder at the injection sites
    - Any uncontrolled systemic disease
    - Recent history of alcohol or drug abuse based on the investigator’s judgement
    - Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention)
    - Anticipated need for surgery or overnight hospitalization during the study
    - Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures
    - Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study, except the prior qualifying lead-in Phase 3 study
    - Females who are pregnant, nursing, or planning a pregnancy during the study. Females of childbearing potential, not using a reliable means of contraception.
    - Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits
    - Participants who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period
    - The participant has a condition or is in a situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events, change from baseline in vital signs, and presence of binding and neutralizing antibodies
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples for immunogenicity testing will be collected on during the retreatment visit and the at the visit 30 days later. This will allow us to detect presence of binding and neutralizing antibodies.

    Vital signs will be performed during the retreatment visit and the at the visit 30 days later. This will allow us to detect changes from baseline.

    E.5.2Secondary end point(s)
    The proportion of participants achieving none or mild on the FWS based on the investigator assessment of GL severity at maximum frown (for 20 U and 44 U groups from Studies -001, -005, and -006) or LCL severity at maximum smile (for 24 U and 44 U groups from
    Studies - 002, -005, and -006)
    • The proportion of participants achieving none or mild on the FWS based on the participant assessment of GL severity at maximum frown (for 20 U and 44 U groups from Studies -001 and -005) or LCL severity at maximum smile (for 24 U and 44 U groups from Studies -002 and -006)
    • The proportion of participants reporting mostly satisfied/very satisfied on the FLSQ follow-up version Item 5 for GL (for 20 U and 44 U groups from Studies -001 and -005) or LCL (for 24 U and 44 U groups from Studies -002 and -006)
    • The proportion of participants with a ≥ 20-point improvement from baseline on the FLSQ Impact domain for GL (for 20 U and 44 U groups from Studies -001 and -005) or LCL (for 24 U and 44 U groups from Studies -002 and -006)
    • The proportion of participants with a ≥ 20-point improvement from baseline on the FLO-11 questionnaire total score for GL (for 20 U and 44 U groups from Studies -001 and -005) or LCL (for 24 U and 44 U groups from Studies -002 and -006)
    • The proportion of participants with a ≥ 4-point improvement from baseline on FLO-11 questionnaire Item 2 for GL (for 20 U and 44 U groups from Studies -001 and -005) or LCL (for 24 U and 44 U groups from Studies -002 and -006).
    • The proportion of participants with a ≥ 4-point improvement from baseline on FLO-11 questionnaire Item 5 for GL (for 20 U and 44 U groups from Studies -001 and -005) or LCL (for 24 U and 44 U groups from Studies -002 and -006)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Germany
    Belgium
    Russian Federation
    United Kingdom
    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
    LPLV
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 760
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 800
    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)
    This is an open label extension study and there no further plans for treatment after the subject has ended the participation in this trial.
    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 Decision2020-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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