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    Summary
    EudraCT Number:2018-001639-35
    Sponsor's Protocol Code Number:M602011014
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-04-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-001639-35
    A.3Full title of the trial
    Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy and safety of NT 201 (botulinum toxin) with placebo for the treatment of lower limb spasticity caused by stroke or traumatic brain injury.
    A.3.2Name or abbreviated title of the trial where available
    PATTERN (Multi-PAttern TreaTment of uppEr and loweR limb with iNcobotulinumtoxinA)
    A.4.1Sponsor's protocol code numberM602011014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03992404
    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 Pharmaceutical 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 pointPublic Disclosure Manager
    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.3.8INN - Proposed INNBotulinum-Toxin Type A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeNT 101
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
    D.3.9.4EV Substance CodeSUB26174
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typeNeurotoxin
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    E.1.1.1Medical condition in easily understood language
    Lower limb or combined lower limb and upper limb spasticity due to stroke or traumatic brain injury
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10058977
    E.1.2Term Spastic paresis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy and safety of 400 U of NT 201 in the treatment of adult lower limb spasticity involving the ankle plantar flexors.
    E.2.2Secondary objectives of the trial
    Evaluation of the long-term safety of NT 201 in the treatment of spasticity with total body doses up to 800 U.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria
    • Female or male subject ≥ 18 years and ≤ 85 years at screening
    • Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    • Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
    • Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
    • Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
    • At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
    • For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
    o Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
    o International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)

    Main eligibility criteria for re-injection
    • According to the experience-based opinion of the investigator, the subject must have a clinical need for 400 U of NT 201 in the affected lower limb
    • Body weight at least 50 kg
    • Negative urine pregnancy test for women of childbearing potential
    • For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
    o aPTT ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
    o INR value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
    • No infection or inflammation in the area of the planned injection sites at the visits
    E.4Principal exclusion criteria
    Main exclusion criteria
    • Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
    • Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
    • Body weight < 50 kg
    • Severe atrophy of the target limb muscles
    • Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
    • Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures:
    o Surgical intervention
    o Alcohol or phenol block
    o Muscle afferent block
    • Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
    • Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia),, or local anesthetics in the treated region within 2 weeks prior to screening
    • Infection or inflammation at the injection sites
    • Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
    • Pregnancy (as verified by a positive pregnancy test) or breast feeding
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy variables:
    • Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at Weeks 4 to 6

    Primary safety variable:
    Occurrence of treatment emergent adverse events [TEAEs] in Main Period
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation of Co-primary efficacy variables:
    • Modified Ashworth Scale-Bohannon (MAS) ankle score at baseline to Weeks 4 to 6


    Timepoint of evaluation of the primary safety variable:
    • Baseline to week 12
    E.5.2Secondary end point(s)
    Key secondary efficacy variable:
    • Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6

    Other secondary efficacy variables:
    • Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
    • Global Impression of Change Scale (GICS) assessed by subject at Week 4 to 6
    • Global Impression of Change Scale (GICS) assessed by caregiver at Week 4 to 6
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Goal Attainment Scale [GAS] at Week 4 to 6
    • GICS assessed by physician at week 4 to 6
    • GICS assessed by subject at Week 4 to 6
    • GICS assessed by caregiver at Week 4 to Week 6.
    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 Yes
    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 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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Switzerland
    Ukraine
    Canada
    United Kingdom
    United States
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Poland
    Slovakia
    Spain
    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
    LVLS
    The End of the entire study, is defined as the date of attendance of the last subject of the final visit of the OLEX period (V17 for subjects with five cycles or V20 with six cycles).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 378
    F.4.2.2In the whole clinical trial 600
    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)
    None
    After study discontinuation, the subjects will be treated by their physician according to their medical condition and standard treatments in the country concerned.
    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 Decision2019-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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