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   43974   clinical trials with a EudraCT protocol, of which   7312   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

    EudraCT Number:2007-000735-26
    Sponsor's Protocol Code Number:AGN/HO/SPA/001-191622
    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:2007-06-12
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-000735-26
    A.3Full title of the trial
    A Multicentre, Double-Blind, Prospective, Randomised, European and Canadian Study to Evaluate Patient Outcomes and Costs of Managing Adults with Spasticity and Associated Focal Spasticity.
    A.3.2Name or abbreviated title of the trial where available
    BOTOX® Economic Spasticity Trial (BEST)
    A.4.1Sponsor's protocol code numberAGN/HO/SPA/001-191622
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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.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. name BOTOX®
    D. of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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.3.4Pharmaceutical 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.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeAGN 191 622
    D.3.9.3Other descriptive nameBOTOX PURIFIED NEUROTOXIN COMPLEX
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 Allergan
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Spasticity and Associated Focal Spasticity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041416
    E.1.2Term 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 evaluate the effectiveness of BOTOX® + Standard of Care (SC) versus placebo + SC for the treatment of adult post-stroke focal spasticity as measured by the number of patients in each arm who achieve their principal functional goal as determined by the physician.
    E.2.2Secondary objectives of the trial
    •To evaluate the effectiveness of BOTOX® + SC versus placebo + SC for the treatment of adult post-stroke focal spasticity;
    - as measured by the number of patients in each arm who achieve their functional goal as determined by the patient.
    - and as measured by the level of functional goal as determined by the patient.
    •Time to reach functional goal attainment as determined by the physician and patient.
    •To evaluate and compare improvement in patient’s quality of life when treated with BOTOX® + SC versus placebo + SC.
    •To collect resource use data from actual clinical practice in the treatment of patients in rehabilitation centres and specialised centres.
    •To evaluate and compare level of resource use of patients on BOTOX® + SC versus placebo + SC.
    •To evaluate and compare the cost, cost-effectiveness and cost-utility of BOTOX® + SC versus placebo + SC.
    •To identify drivers of use of resources and cost.
    •Occurrence of adverse events (AEs) during the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients between 18 and 85 years of age
    2.Patients with stroke due to a primary cerebral haemorrhage/ infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia
    3.Patients suitable for botulinum toxin type A (BOTOX®)
    4.Patients with documented focal/multifocal problems of spasticity in the upper and/or lower limbs and for who functional gains are anticipated after treatment with BOTOX® + SC

    •Patients treated for upper limb spasticity: evidence of preserved antagonist function and at least one item of the REsistance to PAssive movement Scale (REPAS) with a score of at least 1 at the relevant joint(s) for the primary endpoint
    •Patients treated for lower limb spasticity: evidence of preserved standing/ambulation function and at least one item of the REPAS with a score of at least 1 at the relevant joint(s) for the primary endpoint
    5.Patients with spasticity, as defined in criterion #4 above, caused by a stroke that happened 3 months or more before the Screening visit
    6.Female patients either surgically sterile (has had a tubal ligation, documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test is negative and agree to use birth control (e.g. hormonal contraception [estrogen or progesterone agents], intrauterine contraceptive device, double barrier methods [condom with spermicide, diaphragm with spermicide, or male condom and diaphragm], or total sexual abstinence) during the study
    7.Patients able to communicate effectively, with the help of a third person completing answers on their behalf (when required)
    8.Patients willing and able to come to each study protocol visit and answer questions by phone on a monthly basis, possibly with the assistance of a caregiver
    9.Patients willing and able to provide a signed and dated written informed consent
    E.4Principal exclusion criteria
    1.Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated
    2.Patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)
    3.Patients who have been previously treated with botulinum toxin or phenol nerve block in the limbs to be injected during this trial
    4.Patients requiring concomitant use of intrathecal baclofen or phenol nerve block at any point during the study; patients requiring systemic aminoglycoside antibiotics or spectinomycin during the period from at least 3 days before until 6 weeks after injection of study medication.
    5.Patients who are currently taking part in any other clinical trial or have taken part in a clinical trial of a new chemical entity within 6 months prior to Screening
    6.Patients with a Mini-Mental State Examination (MMSE) < 20
    7.Patients not sufficiently motivated to participate in the study as determined by an Apathy Evaluation Scale score > 40
    8.Patients with known medical conditions (e.g. cardiac condition, cancer, etc.) that would affect their ability to benefit from treatment or to complete the study
    9.Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
    10.Patients with myasthenia gravis or Eaton Lambert Syndrome
    11.Patients with infection at the proposed injection site(s)
    E.5 End points
    E.5.1Primary end point(s)
    •comparison of the number of patients in each of the two treatment arms who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive), as determined by the physician, at 10 weeks after the second injection (between 22 and 34 weeks) or at 24-week visit or at time of withdrawal if no second injection has been conducted

    Goal attainment will be measured using the following 6-point Likert scale:

    Score Outcome
    -3 Worse than start
    -2 Equal to start: the patient’s initial condition; no change
    -1 Less than expected: slight improvement, but below the defined therapeutic goal
    0 Expected goal: attains the defined therapeutic goal
    +1 Somewhat more than expected: improvement slightly exceeds the defined therapeutic goal
    +2 Much more than expected: improvements clearly exceed the defined therapeutic goal

    For each patient, two functional goals will be set:
    1) Principal active functional goal
    2) Secondary active or passive functional goal

    For each patient, a principal functional goal will be determined during Baseline visit by the patient and the investigator together, using the following list:
    •Improvement in active function of the upper limb to achieve a personal goal (i.e. dressing, writing/typing, feeding, washing, wheelchair propulsion, other, please specify)
    •Improvement in active function in lower limb to achieve a personal goal (i.e. ability to sit, assisted transfers, independent transfers, wheelchair propulsion, ambulation, climbing stairs, other, please specify)
    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 Yes
    E.6.13.1Other scope of the trial description
    Cost Effectiveness
    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. 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. trial design description
    24 weeks of double-blind treatment followed by a 28 week open-label phase
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 months10
    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 months10
    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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 300
    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 Decision2007-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-26
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands