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    Summary
    EudraCT Number:2005-003951-11
    Sponsor's Protocol Code Number:MRZ60201-0410
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-05
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-003951-11
    A.3Full title of the trial
    Prospective, double-blind, placebo-controlled, randomized, multi-center trial with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke spasticity of the upper limb
    A.4.1Sponsor's protocol code numberMRZ60201-0410
    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.3.8INN - Proposed INNBotulinum A Toxin
    D.3.9.2Current sponsor codeNT101
    D.3.9.3Other descriptive nameClostridium Botulinum Neurotoxin type A (150kD) 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
    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
    Post-stroke spasticity of the upper limb
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10028335
    E.1.2Term Muscle spasticity
    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 efficacy and safety of NT 201 compared to placebo in the treatment of post-stroke spasticity of the upper limb and the influence of treatment on functional impairment and carer burden
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -willingness of the patient to participate as documented by written informed consent.
    -female or male patients at least 18 years
    -at least 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g. neurologist)
    - focal spasticity with at least 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist.
    -focal spasticity with at least 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist
    - Disability Assessment Scale at least 2 points in a principal target domain
    - for pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist
    - for pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX or 200 Units Dysport or 2000 Units Neurobloc (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficalis, digitorum profundus
    -for pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX or 240 Units Dysport or 2400 Units Neurobloc (type B preparation) for flexor carpi radialis
    -negative blood and urine pregnancy test at trial entry for females of childbearing potential
    E.4Principal exclusion criteria
    -spasticity of any other origin than stroke
    -previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)
    -planned concomitant treatment with Botulinum Toxin of any serotype and for any body region
    -previous or planned treatment with phenol- or alcohol-injection in the target limb
    -previous surgical treatment of spasticity in the target muscle(s)
    -fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
    -severe atrophy of the target limb muscles

    -bilateral upper limb paresis/paralysis
    --surgical treatment in the target limb for any indication within the 8 weeks prior to Screening (Visit 1, Day-7)
    -planned surgery in the target limb
    -planned elective surgery under general anesthesia during the Main Period
    -hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin type A
    -change in antispastic medication with centrally acting muscle relaxants (including benzodiazepines) within the 2 weeks prior to Screening (Visit 1, Day -7) and /or antispastic medication with centrally acting muscle relaxants that is intended to be changed during the Main Period.
    -antispastic medication with peripheral muscle relaxants (including dantrolene) within the 2 weeks prior to Screening (Visit 1, Day -7)
    -change in antidepressant medication within the 4 weeks prior to Screening (Visit 1, Day -7) and/or antidepressant medication that is intended to be changed during the Main Period
    -change in physical or occupational therapy regimens (including splinting) within the 2 weeks prior to Screening (Visit 1, Day -7) and/or physical or occupational therapy that is intended to be changed during the Main Period.
    -treatment with intrathecal baclofen within 2 weeks prior to Screening (Visit 1, Day -7)
    -other non-authorized concomitant treatments
    -concomitant rheumatic disease in the target limb, which in the opinion of the Investigator would affect the therapeutic outcome of treatment with Botulinum Toxin
    -other muscle hypertonia (e.g rigidity)
    -current alcoholism or other drug abuse/dependence
    -diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
    -severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), current malignancy or anamnestic HIV infection
    -clinically relevant pathological findings in laboratory parameters, indicating active disease of vital organs
    -anticoagulation therapy which requires an International Normalized Ratio [INR] value of greater than 2.5 or Quick Value of less than 30%
    -INR value of greater than 2.5 on injection day
    -infection in the area of the planned injection points
    -nursing mothers
    -women of childbearing potential without reliable means of contraception (reliable contraception is hormonal contraception or barrier contraception combined with intrauterine contraceptive device) and women planning pregnancy during the course of the trial
    -in the judgement of the Investigator there is severe impairment of cognition that in the opinion of the Investigator does not enable the patient to fully understand the informed consent and participate in the trial
    -in the judgement of the Investigator there is severe impairment of communication (e.g. patients with significant aphasia) that in the opinion of the Investigator precludes the patient participating in the trial
    -participation in a clinical study within the 12 weeks prior to Screening (Visit 1, day -7)
    -previous participation in this clinical study
    -in the opinion of the Investigator the patient is unlikely to complete all study visits (Main Period and OLEX Period)
    -other contraindications which in the Investigator's opinion preclude participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    Responder analysis at Control Visit V4 (Week 4) for patients with an improvement (reduction) of at least 1 ponit from Baseline Visit (V2, Day 0) in the Ashworth Score for wrist flexors.
    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 Yes
    E.8.1.7.1Other trial design description
    Main period is double-blind placebo-controlled followed by open-label extension period
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 Information not present in EudraCT
    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
    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 months4
    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 months4
    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 2005-12-05. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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 different from normal expected treatment
    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 Decision2006-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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