Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-003410-18
    Sponsor's Protocol Code Number:MRZ 60201-0605/1
    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:2007-06-21
    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 number2006-003410-18
    A.3Full title of the trial
    Prospective, single-arm, multicenter trial to investigate the efficacy and safety of NT 201 (botulinum neurotoxin type A free of complexing proteins) and the duration of treatment effect after one injection session and in long-term treatment in patients with cervical dystonia
    A.4.1Sponsor's protocol code numberMRZ 60201-0605/1
    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.3.11 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
    Cervical dystonia, predominantly rotational spasmodic torticollis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.0
    E.1.2Level LLT
    E.1.2Classification code 10064124
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to confirm the safety and efficacy of NT 201 after one injection session in the treatment of patients with cervical dystonia.
    E.2.2Secondary objectives of the trial
    As secondary objectives the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions will be determined. In addition, the usefulness of a patient diary for achievement of optimal treatment during this period in clinical practice will be investigated.
    As part of the safety evaluations during the Main Period and the Extension Period, the incidence of adverse events (AEs) and the formation of antibodies will be investigated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Willingness of the patient to participate as documented by written informed consent
    - Male or female patient aged ≥ 18 and < 76 years
    - A clinical diagnosis of cervical dystonia, i.e., spasmodic torticollis, of predominantly rotational form with a need for injection. Cervical dystonia is characterized by involuntary, inappropriate neuromuscular hyperactivity in neck and shoulder muscles leading to abnormal head movements and postures
    - Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS, see protocol) – total score at baseline ≥ 25
    - TWSTRS – severity score ≥ 10
    - TWSTRS – disability score ≥ 3
    - Patient must be on a stable dose of other medications (if any) used for focal dystonia treatment (e.g., anticholinergics and benzodiazepines) for ≥ 3 months prior to and throughout the Main Period and if possible, throughout the Extension Period
    - Negative pregnancy test at trial entry for female of childbearing potential (premenopausal female or postmenopausal female with last menses less than 12 months ago)
    - Woman of childbearing potential using highly effective methods of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g., condom or diaphragm plus spermicidal cream)
    - For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry.
    - For pre-treated patients only: At least 10 weeks must have passed between the last injection session with botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
    - For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin® or ≤ 1,200 units Dysport®
    For the longterm extension period:
    - Negative pregnancy test for female of childbearing potential (premenopausal female or postmenopausal female with last menses less than 12 months ago)
    - Woman of childbearing potential using highly effective methods of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g., condom or diaphragm plus spermicidal cream)
    - At least 10 weeks must have been passed since the last injection session with botulinum neurotoxin type A for cervical dystonia
    E.4Principal exclusion criteria
    - Pre-treatment with botulinum neurotoxin type B (Neurobloc®) at any time prior to study entry
    - Concomitant treatment with botulinum neurotoxin of any serotype for any other indication (including aesthetic indications) and for any body region during the trial
    - Traumatic torticollis and tardive torticollis
    - Previous or planned myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation and/or spinal cord stimulation)
    - Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A
    - Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
    - Severe swallowing disorder of any origin (Dysphagia Scale score ≥ 3 = severe, with swallowing difficulties and requiring a change in diet)
    - Predominantly marked limitation on passive range of motion that clinically suggests fixed structures, e.g., cervical contractures or cervical spine syndrome
    - Present or pre-existing blood coagulation disorders including therapeutic or prophylactic anticoagulation (e.g., heparin, phenprocoumon)
    - Infection in the area of the planned injection sites or systemic infection presenting a hazard for local injections into the neck muscles
    - Non-authorized concomitant treatment (see protocol section Prior and Concomitant Therapy)
    - Current participation in another investigational clinical trial or participation in a clinical trial within the past 3 months
    - Inability of patient to give informed consent
    - Nursing mother
    - Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or known HIV infection in medical history
    - Planned elective surgery under general anesthesia during the trial
    - Known current alcoholism or other drug abuse/dependence
    - Being an employee or direct relative of an employee of the involved CRO, the Study Center or Merz Pharmaceuticals
    For the long-term extension period:
    - Concomitant treatment with botulinum neurotoxin of any serotype for any other indication (including aesthetic reasons) and for any body region during the trial
    - Planned myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation and/or spinal cord stimulation)
    - Severe swallowing disorder of any origin (Dysphagia Scale score ³ 3 = severe, with swallowing difficulties and requiring a change in diet
    - Predominantly marked limitation on passive range of motion that clinically suggests fixed structures, e.g., cervical contractures or cervical spine syndrome
    - Present or pre-existing blood coagulation disorder including therapeutic or prophylactic anticoagulation (e.g., heparin, phenprocoumon)
    - Infection in the area of the planned injection sites or systemic infection presenting a hazard for local injections into the neck muscles
    - Non-authorized concomitant treatment (see protocol section Prior and Concomitant Therapy9.4.7)
    - Nursing mother
    - Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection
    - Planned elective surgery under general anesthesia during the trial
    - Known current alcoholism or other drug abuse/dependence
    E.5 End points
    E.5.1Primary end point(s)
    TWSTRS – total score : Change from baseline to week 4 after initial injection session
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned20
    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 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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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 2007-06-21. 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 state74
    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 Decision2007-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 10:36:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA