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    Summary
    EudraCT Number:2011-001318-32
    Sponsor's Protocol Code Number:P261-401
    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:2012-07-02
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-001318-32
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of
    the Safety and Efficacy of Intranasal Midazolam (USL261) in
    the Outpatient Treatment of Subjects with Seizure Clusters
    ARTEMIS-1: Acute Rescue Therapy in Epilepsy with
    Midazolam Intranasal Spray-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    ARTEMIS-1: Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1
    A.4.1Sponsor's protocol code numberP261-401
    A.5.4Other Identifiers
    Name:US IND numberNumber:77,421
    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 SponsorUpsher-Smith Laboratories, Inc.
    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 supportUpsher-Smith Laboratories, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinVentiv Health Clinical UK Limited
    B.5.2Functional name of contact pointRegulatory Operations
    B.5.3 Address:
    B.5.3.1Street AddressThames House, 17-19 Marlow Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 7AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628587430
    B.5.5Fax number+441628 408428
    B.5.6E-mailRegOpsEurope@inventivhealth.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 No
    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 nameIntranasal midazolam
    D.3.2Product code USL261
    D.3.4Pharmaceutical form Nasal spray, solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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.3.9.2Current sponsor codeUSL261
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray, solution in single-dose container
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    epilepsy
    E.1.1.1Medical condition in easily understood language
    epilepsy
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10015052
    E.1.2Term Epileptic seizure
    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 efficacy of USL261 compared with that of IN placebo for the outpatient treatment of seizure clusters based on Treatment Success, which is defined as achieving both of the following:
    •Termination of seizure(s) within 10 minutes after study drug administration, and
    •No recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration Refer to protocol for further objectives.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of USL261 compared with that of IN placebo for the outpatient treatment of seizure clusters using the following:
    •Proportion of subjects with recurrence of seizure(s) beginning 10 minutes after study drug administration to 4 hours after study drug administration
    •Time to next seizure with a start time > 10 minutes after study drug administration
    Refer to protocol for further objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subject or subject's legally acceptable representative (LAR) has provided written informed consent, and subject has provided written assent where required by local law or Institutional Review Board/Independent Ethics Committee policy
    •Subject has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
    •Subject is 12 years of age or older, at Visit 1
    •Subject has an established diagnosis of partial or generalized epilepsy that includes all of the following:
    - A documented history of seizure clusters lasting a minimum of 10 minutes from the time the seizure cluster is recognized
    - The seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any) in seizure type, duration, severity or frequency
    - As part of the subject's stereotyped seizure cluster pattern, a second seizure typically occurs within 6 hours from the time of recognition of the seizure cluster
    - In the investigator's opinion, it would be safe for the subject to receive placebo as a first dose of study drug followed by active treatment (USL261) as the second dose of study drug no earlier than 10 minutes after the first dose
    - The subject's stereotyped seizure cluster pattern is composed of multiple (≥2) partial or generalized seizures
    - The subject's stereotyped seizure cluster pattern was established > 3 months before Visit 1
    - A frequency of ≥3 stereotyped seizure clusters during the year before Visit 1
    - At least 1 stereotyped seizure cluster occurring ≤4 months before Visit 1
    - The seizure cluster pattern described above is confirmed by a central reviewer
    •Currently on a stable regimen of AEDs since Visit 1 and for ≥7 days before Visit 2.
    E.4Principal exclusion criteria
    •Subject has a neurological disorder that is likely to progress in the next year
    •Subject has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
    •Subject has a history of their stereotypical seizure cluster progressing to status epilepticus (as determined by the investigator) within the 2 years before Visit 1
    •Subject has acute narrow-angle glaucoma.
    •Subject has had an active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 as defined by a Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation score ≥3, any suicide attempt in the past 5 years as determined by the C-SSRS or medical history, or other clinically significant suicidality as determined by the investigator
    •Subject is currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the settings have not changed within 4 weeks before Visit 1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects who meet the criteria for Treatment Success.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Success is a composite measure of efficacy that will be
    assessed based upon the first seizure cluster treated during the Comparative Phase. Treatment Success is defined as achieving the following:
    •Termination of seizure(s) within 10 minutes after study drug administration, and
    •No recurrence of seizure(s) beginning 10 minutes after administration of study drug to 6 hours after study drug administration
    E.5.2Secondary end point(s)
    •Proportion of subjects with recurrence of seizure(s) beginning 10 minutes after administration of study drug to 4 hours after administration of study drug
    •Time to next seizure with a start time > 10 minutes after study drug administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Proportion of subjects with recurrence of seizure(s): beginning 10 minutes after administration of study drug to 4 hours after administration of study drug
    •Time to next seizure with a start time > 10 minutes after study drug 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 Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open-label test-dose phase, followed by double-blind comparative 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Canada
    European Union
    Israel
    New Zealand
    Ukraine
    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 Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 283
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    adolescent patients aged 12 to 17 years
    cognitively impaired subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 350
    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)
    No difference to the expected normal treatment of that condition.
    Subjects will be offered the opportunity to roll over into the extension
    study P261-402 (EudraCT no.: 2011-004109-25).
    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 Decision2012-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-22
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