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    Summary
    EudraCT Number:2021-002051-10
    Sponsor's Protocol Code Number:SHP615-302
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-04-13
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-002051-10
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients with Status Epilepticus (Convulsive) in Community Settings
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Submission of Clinical Study Result for Pediatric Study SHP 615 - 302
    A.4.1Sponsor's protocol code numberSHP615-302
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/155/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center, Americas (TDC Americas)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Center, Americas (TDC Americas)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Lesvi
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressAv. Barcelona, 69
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08970
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493 602 2429
    B.5.5Fax number+3493 373 87 51
    B.5.6E-mailnxregulatory@neuraxpharm.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 Buccolam oromucosal solution
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Lesvi
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDAZOLAM
    D.3.9.1CAS number 59467-70-8
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children, and adolescents (from 3 months to < 18 years)
    E.1.1.1Medical condition in easily understood language
    Convulsions in children aged 3 months to less than 18 years
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 this study was to assess the efficacy of buccally administered midazolam hydrochloride oromucosal solution (MHOS/SHP615) in pediatric subjects with status epilepticus (SE; convulsive) in the community setting.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study was to assess the safety of buccally administered MHOS/SHP615 in pediatric subjects with SE (convulsive) in the community setting.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects who completed the SHP615-301 study and who tolerated and responded to treatment with MHOS/SHP615 in the hospital and/or emergency room and were considered stable for discharge from the hospital.
    - Subjects who were more than 6 months and less than 18 years of age at the time of MHOS/SHP615 administration. If the subject's exact age was not known, the subject was excluded.
    -Subjects who experienced generalized tonic-clonic SE with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration:
    Presented, at the time, with seizure (convulsive) activity and 3 or more convulsions within the preceding hour;in succession without recovery of consciousness or presented, at the time, with a single seizure (convulsive) persisting ≥5 minutes.
    E.4Principal exclusion criteria
    - Female subjects who were pregnant, suspected to be pregnant, or nursing.
    - Subjects with major trauma, not necessarily restricted to the head, as the cause of the seizure.
    - Subjects with major trauma, not necessarily restricted to the head, as the cause of the seizure.
    - Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal.
    - Subjects with seizures due to illegal drug or acute alcoholic intoxication
    - Subjects with seizures of psychogenic origin
    - Subjects with seizures due to severe cases of encephalitis or meningitis, as determined by the investigator.
    - Subjects with a known history of hypersensitivities, nonresponsiveness or contraindications to benzodiazepines (ie, clinically significant respiratory depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea, glaucoma with closed angle, or use of concomitant drugs determined by the investigator to have a contraindication to the use of benzodiazepines.)
    - Subjects with a known history of benzodiazepine abuse.
    - Subjects who had not responded to previous administrations of midazolam systemic therapies, including Midafresa and/or Dormicum.
    - Subjects who needed emergent surgical intervention and general anesthesia/intubation.
    - Subjects who had been receiving human immunodeficiency virus (HIV) protease inhibitors or HIV reverse transcriptase inhibitors.

    Subjects with severe cerebral anoxia (except cerebral palsy), in the judgment of the healthcare provider.
    Had used an IP or been enrolled in a clinical study (including vaccine studies) that, in the investigator’s opinion, may impact this TDC Americas-sponsored study.
    Subject had prior placement of a vagus nerve stimulator.
    E.5 End points
    E.5.1Primary end point(s)
    Seizure to stop after administration of Bucolam
    E.5.1.1Timepoint(s) of evaluation of this end point
    Seizure to stop within 10 minutes after administration of Bucolam
    E.5.2Secondary end point(s)
    No seizures to be observed after administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    No seizures to be observed during the first hour after administration
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    The study was ended after 3 subjects completed the study assessments as per the agreement with the Japanese regulatory authority, Pharmaceuticals and Medical Devices Agency (PMDA), that the study would be closed upon NDA approval. Therefore, the final SHP6150-302 study report is based on data available up to 13 October 2020 (last subject completed date), to be concurrent with the Study SHP615-301 report: 3 patients were analyzed for safety; 3 patients were analyzed for efficacy.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 6
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 6
    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)
    Buccal administration of an age-stratified dose of MHOS/SHP615 for the management of SE in a community setting was effective and well tolerated in all subjects who received treatment to date.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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