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    Summary
    EudraCT Number:2019-003647-29
    Sponsor's Protocol Code Number:SN-SPAS-202
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-03-02
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003647-29
    A.3Full title of the trial
    A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity Followed by an Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of MYOBLOC® in the Treatment of Adults withincreased muscle tone in a lower extremity or extremities leading to difficulties of movement and walking and followed by an Open-Label Multiple-Treatment Safety Study
    A.4.1Sponsor's protocol code numberSN-SPAS-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04099667
    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 SponsorSolstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
    B.1.3.4CountryUnited States
    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 supportSolstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSolstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address9715 Key West Avenue
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number(301) 838-2607
    B.5.5Fax number(240) 403-0065
    B.5.6E-mailtmartin@supernus.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 NeuroBloc 5000 U/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderSloan Pharma S.à.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNRimabotulinumtoxinB
    D.3.9.1CAS number 93384-44-2
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE B
    D.3.9.4EV Substance CodeSUB12472MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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 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 placeboSolution 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
    Lower Limb Spasticity
    E.1.1.1Medical condition in easily understood language
    Increased muscle tone in lower extremity or extremities leading to difficulties of movement and walking.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041416
    E.1.2Term Spasticity
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess the efficacy of MYOBLOC versus placebo in the treatment of adult lower limb spasticity.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are:
    • To establish a dose response between 2 active doses of MYOBLOC versus placebo.
    • To assess the duration of therapeutic response after a single administration of MYOBLOC.
    • To evaluate the long-term safety and tolerability of MYOBLOC after multiple administrations at approximately 13-week intervals over a minimum duration of 1 year.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study; if unable, the subject’s Legally Authorized Representative (LAR) may provide written informed consent.
    2. Male or female ≥18 to maximum of 80 years of age, inclusive.
    3. Lower limb spasticity due to stroke, traumatic brain injury (TBI) or spinal cord injury that occurred ≥6 months prior to randomization. Eligible subjects may have lower limb monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment.
    4. Ambulatory (with or without the use of a walking assistive device).
    5. Modified Ashworth Scale (MAS) score ≥2 in the ankle plantar flexors of the affected lower limb at screening and at baseline.
    6. In the Investigator’s opinion, the subject will be available and able to comply with the study requirements for at least 1 year, based on the subject’s overall health and disease prognosis.
    7. In the Investigator’s opinion, the subject will be willing and able to comply with all requirements of the protocol, including completion of study questionnaires. A caregiver may be designated to assist with the physical completion of questionnaires/scales.
    E.4Principal exclusion criteria
    1. Quadriplegia/tetraplegia, lower limb diplegia or triplegia
    2. Uncontrolled epilepsy or any type of seizure disorder with a seizure(s)
    within the previous year.
    3. Neuromuscular disorders including, but not limited to, amyotrophic
    lateral sclerosis, primary lateral sclerosis, multiple sclerosis, myasthenia
    gravis, or muscular dystrophy.
    4. History of major joint contracture(s), in which, based on Investigator
    assessment, the contracture(s) significantly contribute to joint
    immobility in the affected lower limb.
    5. Unresolved fracture(s) in the affected lower limb.
    6. Severe atrophy in the affected lower limb.
    7. Known hypersensitivity to BoNT/ A or BoNT/B or to any MYOBLOC
    solution components
    8. Concomitant use or exposure within 5 half-lives of randomization of
    the following: aminoglycoside antibiotics, curare-like agents, or other
    agents that may interfere with neuromuscular function.
    9. Treatment with a neurolytic agent (e.g., phenol, alcohol blocks) to the
    affected lower limb within 1 year before randomization.
    10. Presence of a spinal stimulator or intrathecal baclofen pump that has
    not been turned off within 30 days before screening.
    11. Changes to treatment regimen or any new treatment with oral antispasmodics and/or muscle relaxants within 30 days before
    randomization.
    12. Initiation of physical and/or occupational therapy <30 days before
    randomization. Subjects receiving physical and/or occupational therapy
    ≥30 days before randomization must be willing to maintain their therapy
    regimen through Week 4 of the DBP.
    13. Application of an ankle-foot orthosis (AFO) <30 days before
    randomization. Subjects regularly using an AFO >30 days before
    randomization must be willing to maintain use of the AFO through Week
    4 of the DBP.
    14. Prior BoNT/A or BoNT/B treatment in the affected lower limb within
    24 weeks before screening. Prior BoNT/A or BoNT/B treatment in areas
    other than the affected lower limb is not exclusionary but must have
    occurred at least 12 weeks before screening. Prior toxin exposure must
    have been well tolerated & without any significant long-term side effects
    in case of repeated prior exposure.
    15. Subjects should not receive nor have any plans to receive any
    botulinum toxin treatment, other than study drug (MYOBLOC), from the
    point informed consent is obtained until study participation is complete
    16. Severe dysphagia (i.e. inability to swallow liquids, solids/both
    without choking/medical intervention) or dysphagia with a history of
    aspiration pneumonia within 6 months before screening
    17. Prior surgery to treat spasticity in the affected lower limb (i.e tendon lengthening or tendon transfer).
    18. Any anticipated/scheduled surgery during study period with
    exception of dermatological procedures performed under local
    anesthesia for purposes of removing precancerous and cancerous
    lesions.
    19. Major surgery within 3 months before screening.
    20. Pregnancy/breastfeeding.
    21. Females of childbearing potential must agree to use a medically
    acceptable method of contraception (e.g., intrauterine device, hormonal
    contraception started at least 1 full cycle before study enrollment or
    sexual abstinence for duration of study (including 2 months after study completion). For purposes of this study, all females are considered to be
    of childbearing potential unless they are confirmed by Investigator to be
    post-menopausal (at least 1 year since last menses, & laboratory test
    confirmation) biologically sterile, or surgically sterile (e.g., hysterectomy
    with bilateral oophorectomy, tubal ligation).
    22. History of drug/alcohol abuse within 6 months before screening.
    23. Obstructive pulmonary disease with (FEV1)/forced vital capacity (FVC) <70%.
    24. Slow vital capacity (SVC) <60% of predicted.
    25. Chronic/current use of inhaled corticosteroids.
    26. Ventilator dependence.(i.e. 24-hour ventilator dependence when
    intubated, or due to a failure to wean subject from ventilator while
    hospitalized in intensive care unit or respiratory care center)
    27. Infection at the planned sites of injection
    28. Treatment with an investigational drug, device, or biological agent
    within 30 days before screening or while participating in this study
    29. Malignancy diagnosed 3 months before screening.
    30. Has one/more screening clinical laboratory test values outside
    reference range that are clinically significant or any of the below:
    - Serum creatinine >1.5 times the upper limit of normal (ULN)
    - Serum total bilirubin > 1.5 times ULN
    - Serum alanine aminotransferase or aspartate aminotransferase >2
    times ULN.
    31. Has any of following cardiac findings at screening:
    - Abnormal ECG that is, in Investigator's opinion/evaluation clinically
    significant
    - PR interval >220 ms
    - QRS interval >130 ms
    - QTcF interval >450 ms (for men) or >470 ms (for women)
    - Second-or third-degree atrioventricular block
    - Any rhythm other than sinus rhythm, that is assessed by Investigator
    to be clinically significant
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2 and Phase 3 of the Double-Blind Period:
    • Change from baseline in tone of the ankle plantar flexors as measured by the MAS at Week 4 post-injection
    • Clinical Global Impression of Change (CGI-C) in functional ability at Week 4 postinjection
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 post-injection
    E.5.2Secondary end point(s)
    Secondary Efficacy endpoints:
    Phase 2 and Phase 3 of the Double-Blind Period
    Change from baseline at Week 4 post-injection in:
    • Patient Global Impression of Change (PGI-C)
    • Caregiver Global Impression of Change (GGI-C)
    • Pain-NRS
    • WIQ
    • WRCS
    • Responder rate, defined as the percent of subjects with ≥1 grade reduction in their MAS score compared to their baseline score at Week 4 in the ankle plantar flexors

    Change from baseline at Weeks 2, 8, and 13 and if applicable, at reevaluation visits in:
    • Tone in the ankle plantar flexors as measured by the MAS
    Tone in the ankle plantar flexors as measured by the MAS
    • Duration of response by measuring the time elapsed between the
    injection and relapse of spasticity (MAS ≥2)
    • CGI-C and Clinical Global Impression of Severity (CGI-S)
    • PGI-C and Patient Global Impression of Severity (PGI-S)
    • GGI-C and Caregiver Global Impression of Severity (GGI-S)
    • Pain Numeric Rating Scale (Pain-NRS)
    • Walking Impairment Questionnaire (WIQ)
    • Walking and Resting Comfort Scale (WRCS)

    Open-Label Extension:
    • Duration of response by measuring the time elapsed between the
    injection and relapse of spasticity (MAS ≥2)

    Exploratory Efficacy Endpoints:
    Phase 2 and Phase 3 of the Double-Blind Period
    • Change from baseline at all weeks in tone of the ankle plantar flexors
    when the baseline MAS was ≥2
    • Responder rate defined as the percent of subjects with a ≥1 grade
    reduction in their MAS score at all weeks in the ankle plantar flexors
    compared to baseline

    Open-Label Extension
    Affected lower limb: Change from Day 1 at Weeks 4 and 13 and if
    applicable, at reevaluation visits of each treatment session in:
    • Tone in the ankle plantar flexors as measured by the MAS
    • Tone in any additional muscles selected for injection as measured by
    the MAS
    • CGI-C and CGI-S
    • PGI-C and PGI-S
    • GGI-C and GGI-S
    • Pain-NRS
    • WIQ
    • WRCS
    Upper limb (if injected): Change from Day 1 at Weeks 4 and 13 and if
    applicable, at reevaluation visits of each treatment session in:
    •Tone in muscles selected for injection as measured by the MAS
    • CGI-C and CGI-S
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to Q E.5.2
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    randomized, double-blind, placebo-controlled followed by open-label extension
    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 trial5
    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 EEA13
    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
    Czechia
    Hungary
    Poland
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last Patient Last Visit
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 232
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 272
    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
    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 Decision2020-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-02-16
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