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    Summary
    EudraCT Number:2011-004980-63
    Sponsor's Protocol Code Number:191622-116
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-16
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-004980-63
    A.3Full title of the trial
    BOTOX® Treatment in Adult Patients with Post-Stroke Lower Limb Spasticity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with BOTOX® for patients with post-stroke leg muscle tightness
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code number191622-116
    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 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 supportAllergan Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointEU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow,International, The Parkway, Marlow
    B.5.3.2Town/ cityBuckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)1628 494444
    B.5.5Fax number+44 (0)1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 Yes
    D.2.1.1.1Trade name BOTOX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameBOTOX®
    D.3.2Product code 9060X
    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 codeAGN 191622
    D.3.9.3Other descriptive nameBotox purified neurotoxin complex
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U 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) 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 Yes
    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
    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 Lower Limb Spasticity
    E.1.1.1Medical condition in easily understood language
    Post-Stroke Lower Limb Spasticity
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10042244
    E.1.2Term Stroke
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10024132
    E.1.2Term Leg spasticity
    E.1.2System Organ Class 100000004852
    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 safety and efficacy of a single treatment of BOTOX (300 units (U) plus optional dose up to 100 U) in the treatment of adult post-stroke lower limb spasticity involving the ankle plantar flexors
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. male or female, ≥18 to ≤ 85 years of age at the screening visit
    2. patients who are diagnosed with post-stroke lower limb spasticity present with equinus (plantar flexion of the ankle) or equinovarus deformity, with the most recent stroke occurring at least 3 months prior to the screening visit
    3. a minimum body weight of 50 kg at the screening visit
    4. written informed consent has been obtained
    5. written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g. Written Authorization for Use and Release of Health and Research Study Information (United States [US] sites) and written Data Protection consent (European Union [EU] sites).
    6. MAS-B score of ≥ 3 in the ankle plantar flexors at both screening and day 1 visits
    7. botulinum toxin treatment-naïve or if previously treated with botulinum toxin of any serotype:
    - ≥ 20 weeks prior to the day 1 visit if treated for spasticity of the study limb, or
    - ≥ 12 weeks prior to the day 1 visit if treated for an indication other than spasticity of the study limb
    8. acceptable clinical laboratory results at screening at the investigator’s
    discretion
    9. for females of childbearing potential, a negative urine pregnancy test at screening and on the day 1 visit
    10. patients who are on spasmolytic medications or muscle relaxants (eg, oral baclofen, tizanidine, dantrolene, scopolamine [oral or patch], vigabatrin, or benzodiazepine therapy) must be on a stable dose and regimen for at least 2 months prior to the day 1 visit
    11. patients who are on anti-epileptic medications must be on a stable dose and regimen for at least 1 month prior to the day 1 visit
    E.4Principal exclusion criteria
    1. patients with spasticity in the contralateral leg that requires treatment
    2. presence of fixed contractures of the ankle (absence of range of motion) in the study leg
    3. profound atrophy of the muscles to be injected at the investigator’s discretion
    4. previous surgical intervention, phenol block, ethanol block, or muscle afferent block:
    a) prior to screening for the treatment of spasticity in the study limb for muscles eligible for double-blind treatment, or
    b) within 6 months prior to screening for any other muscles in the upper or lower limbs
    5. casting of the study limb within 6 months prior to the screening visit and/or plans to cast the study limb during the double-blind phase of the study
    6. treatment modalities in the study limb, including ultrasound therapy, transcutaneous electrical nerve stimulation, electrical stimulation, or acupuncture within 1 month of the day 1 visit or planned during the double-blind phase of the study
    7.etiology other than stroke contributing to lower limb spasticity (eg, multiple sclerosis, traumatic brain injury, spinal cord injury)
    8. infection of local skin, soft tissue, and joint in the areas to be injected or patients at a high risk of infection (eg, under immunosuppression treatments)
    9. history of severe, progressive, or current unstable medical conditions as determined by medical history, physical examination and /or laboratory tests
    10. patients with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function per investigator’s clinical judgment
    11. patients with an active malignancy of any type or a history of malignancy within the last 5 years (except basal cell carcinoma of the skin or squamous cell carcinoma of the skin with clean margins that has been excised at least 12 weeks prior to screening)
    12. history of substance abuse or dependence within 12 months prior to the screening visit, excluding nicotine and caffeine
    13. known allergy or sensitivity to the study medication(s) or its components
    14. nonambulatory patients defined as patients not able to perform the 10 meter walking test independently with or without assistive device
    15. females who are pregnant, nursing, or planning a pregnancy during the study period
    16. females of childbearing potential, not using a reliable means of contraception [See protocol Section 4.5.1.1 for definition of acceptable methods of contraception]
    17. current enrollment in an investigational drug, nonpharmacological treatment or interventional device study or participation in such a study within 30 days prior to the screening visit
    18. any medical or neurological condition that may put the patient at increased risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant diseases or concomitant medications that might interfere with neuromuscular function
    19. Patient has a condition, is planning a surgery requiring general anesthesia during the study, or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
    20. Patients on intrathecal baclofen pump
    21. Physical therapy (physiotherapy) or use of static or dynamic splints including dynamic ankle foot orthosis (AFO), in the study limb that is initiated less than 14 days prior to the day 1 visit or that is expected to change during the double-blind phase of the study. Physical therapy or splint use including AFO is allowed to be changed or initiated during the open-label phase.
    22. Patients with a MRC muscle strength score of ≤ 3 in any of the muscles measured in the contralateral leg at the screening visit
    23. Previous surgery of the study limb that in the investigators opinion, either significantly impairs motor function, will make outcome measures unreliable, or will confound efficacy results of the study
    24. Patients who have a significant risk of suicide, defined as a "yes" answer to one or both of the following questions on the C-SSRS, either at the screening visit (when assessing the prior 12 months) or at the day 1 visit (when assessing the time since the screening visit):
    a) Questions 4 or 5 on the suicidal ideation section
    b) Any questions on any item in the suicidal behavior section
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy measure is MAS-B score for the ankle plantor flexors and CGI by Physician (analysis as a co-primary efficacy measure is for US FDA only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every clinic visit MAS-B will be performed by the investigator
    E.5.2Secondary end point(s)
    Secondary measures:
    • Clinical Global Impression of Change CGI by Physician
    • MAS-B for optional muscles (flexor digitorum longus, flexor digitorum brevis, flexor hallucis longus, extensor hallucis, and rectus femoris) in a subset of patients who receive study treatment in the optional muscles
    • Goal Attainment Scaling (GAS) by Physician and Patient
    • Pain Scale (11-point numeric rating scale)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments are done during the study visits: CGI - visits at week 2, 4, 6, 8, 12, open label treatments day 1 visits and week 6 visits, exit visit; MAS-B for optional muscles - at every clinic visit; GAS - visits at week 8, 12, open label treatments day 1 and week 6 visits, exit visit; Pain Scale - visits at day 1, week 2, 4, 6, 8, 12, open label treatments day 1 and week 6, exit visit
    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
    open label phase after the double-blinded 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.8.2.4Number 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Czech Republic
    Germany
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    United Kingdom
    United States
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 222
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 196
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 368
    F.4.2.2In the whole clinical trial 418
    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)
    The patients will return to previous treatment options as per standard of care for the indication in the country /hospital
    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 Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-01
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