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    Summary
    EudraCT Number:2012-000188-25
    Sponsor's Protocol Code Number:LoveMi
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-03-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000188-25
    A.3Full title of the trial
    Lormetazepam versus Midazolam used as sedatives for critically ill
    patients.
    Lormetazepam versus Midazolam als Basissedativum
    für intensivpflichtige Patienten
    Multizentrische, randomisierte, kontrollierte, prospektive, doppelblinde, zweiarmige klinische Prüfung nach dem AMG, Phase IV mit Rekalkulation der Fallzahl.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Lormetazepam and Midazolam used as sedatives for patients that require intensive care.


    Lormetazepam versus Midazolam als Beruhigungsmittel
    für intensivpflichtige Patienten
    A.3.2Name or abbreviated title of the trial where available
    LoveMi
    A.4.1Sponsor's protocol code numberLoveMi
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02022592
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité - Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointUniv.-Prof. Dr. C. Spies
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930551 001 / 02
    B.5.5Fax number+4930551 909
    B.5.6E-mailclaudia.spies@charite.de
    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 SEDALAM® 2 mg/10 ml
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Franz Köhler Chemie GmbH
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPR1: Lormetazepam
    D.3.9.1CAS number 848-75-9
    D.3.9.3Other descriptive nameLORMETAZEPAM
    D.3.9.4EV Substance CodeSUB08588MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Midazolam-hameln® 100 mg/50 ml
    D.2.1.1.2Name of the Marketing Authorisation holderhameln pharmaceuticals GmbH
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPR2: MIDAZOLAM
    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 typeequal
    D.3.10.3Concentration number2
    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
    Sedation
    E.1.1.1Medical condition in easily understood language
    Tranquilizing
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    “Controllability of sedation”; this is defined as the percentage share of measures where the actual depth of sedation (measured with the Richmond Agitation and Sedation Scale) (RASS)) matches the target depths of sedation. The individual sedation target is defined by the attending physician.
    E.2.2Secondary objectives of the trial
    1) Incidence of newly developed complications
    2) SOFA Score
    3) Pain
    4) Anxiety
    5) Concurrent medication for Analgesia and Sedation
    6) Delirium
    7) Mortality
    8) Duration of mechanical ventilation and weaning from mechanical ventilation
    9) Length of ICU stay
    10) Length of hospital stay
    11) Discharge mode
    12) Length of sedation
    13) Number of changes in target sedation depth
    14) Wake-up-time
    15) Deviation from target sedation depth
    16) Quality of Life
    17) Cognition
    18) Posttraumatic stress disorder
    19) Pain threshhold measurement (only Center Charité and Gießen)
    20) Depth of sedation (EMG/EEG) (surgery patients: Center Charité and Gießen, intensive care unit patients: Center Charité)
    21) Photomotor reflex (only Center Charité)
    22) Plasma activity of acetylcholine esterase
    23) MicroRNA (only Center Charité)




    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Mechanically ventilated ICU patients with the need for sedatives
    to achieve or maintain the intended target-RASS (surgical/ non-surgical).
    -Age ≥ 18 years
    -Patients who are incapable of giving consent at study inclusion: Written informed consent by patient’s legal representative or an independent medical consultant, patients give informed consent subsequent if they are capable.
    - Patients who are able to give informed consent at study inclusion: Written informed consent by patients for planned postoperative prolonged ventilatory support who undergo general surgery
    - Patients who are able to give informed consent at study inclusion and have the need for intubation with analgosedation
    E.4Principal exclusion criteria
    -Any bolus administration of benzodiazepines until 72hrs before
    inclusion (except from premedication due to anaesthesia).
    - Continuous administration of benzodiazepines within the last 7 days before start of study drug application
    - Titration phase: No possibility that the target RASS (-3 - 0) can be set by the treating physician
    -Known drug intolerance or allergy against lormetazepam,
    midazolam or one of the additional components.
    -Addictive disorder
    -Increased intracranial pressure
    -Acute intoxication with alcohol, analgesics, sedatives,
    antipsychotics (neuroleptics, anti-depressives, lithium).
    -Patients with cerebrale Pathology, which changes the controllability of sedation or die consciousness (e.g. patients known mental retardation due to syndromatic disorders or an
    infantile brain damage)
    -Patients with a suspected or secured hypoxic brain damage
    - Patients with intracranial surgery during actual hospital care
    - Tetraplegic patients
    -Myasthenia Gravis
    -Cerebellar or spinal Ataxia
    -Moribund patients with an expected lifespan of less than 24
    hours.
    -Sickle cell anaemia
    -Thallassemia
    -Enzyme related disorders that are associated with a severe
    decreased activity of UDP-glucoronyltransferase (e.g. M. Crigler-
    Najjar)
    - Chronic liver insuffiviency CHILD C with MELD Score >
    17 before access to intensive care unit
    - Diagnosed propofol intolerance/anamnestic propofol infusion syndrome
    - known depression/suicidality
    -Pregnancy (positive beta-HCG test from urine or positive beta-HCG laboratory test from serum (in anuric patients the serum beta-HCG test is obliged) or lactation
    -Woman of child-bearing potential who are not using a highly
    effective contraception (Pearl – Index <1) until 3 monthes after study inclusion and during this trial
    -Referral following an order of official authorities (court order or
    administrative decision) according to German Drug Law (AMG)
    §40 (1) 4
    -Participation in clinical trials according to the German Drug Law
    (AMG) 30 days to and during the study
    -Local staff
    E.5 End points
    E.5.1Primary end point(s)
    “Controllability of sedation”; this is defined as the percentage share of measures where the actual depth of sedation (measured with the Richmond Sedation and Agitation Scale
    (RASS)) matches the target depths of sedation. The individual sedation target is defined by the attending physician.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be measured for 3 days on ICU.
    E.5.2Secondary end point(s)
    1) Incidence of newly developed complications (cardiovascular, pulmonal, gastrointestinal, renal, cerebral und infectious)
    2) SOFA
    3) Pain-Scores (NRS-V; FPS-R; BPS; BPS-NI according to German consensus guidelines)
    4) Anxiety-Score (FAS)
    5) Concurrent medication for Analgesia and Sedation (dose/time)
    6) Delirium-Screening-Instruments (CAM-ICU/ICDSC/Nu-DESC)
    7) Mortality (days)
    8) Duration of mechanical ventilation and weaning from mechanical ventilation (days)
    9) Length of ICU stay (days)
    10) Length of hospital stay (days)
    11) Discharge mode (days)
    12) Length of sedation (days)
    13) Number of changes in target RASS
    14) Wake-up-time (hours)
    15) Deviation from target RASS
    16) Quality of Life (EQ-5D)
    17) Cognition (MMSE, FEDA, MWT)
    18) Posttraumatic stress disorder (PTSS-14)
    19) Pain threshold measurement (only Center Charité and Gießen)
    20) Depth of sedation (EMG/EEG) (surgery patients at Center Charité and Gießen, intensive care unit patients at Center Charité)
    21) Photomotor reflex (only Center Charité)
    22) Plasma activity of acetylcholine esterase
    23) MicroRNA (Center Charité)

    E.5.2.1Timepoint(s) of evaluation of this end point
    1) will be measured until 5 days after termination of study drug .
    13) and 14) and 15 ) will be measured until termination of study drug.
    2) and 5) and 20) and 21) and 22) will be measured as long as patient is treated on ICU but not longer than 5 days after study drug termination.
    3) and 4) and 6) will be measured until study day 28 or discharge.
    18) MMSE and MWT and FEDA will be measured at 28 days (or discharge) and FEDA at 90 days.
    8) and 9) and 10) and 11) and and 12) and 16) and 17) and 18) will be measured at follow up (day 90).
    19) will be measured during the intervention of 2 days
    For 7) there will be a daily assessment and an assessment at follow up.
    23) will be measured at inclusion and 24 hours later
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Midazolam
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients from Intensive Care Units and patients who undergo general surgery
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    After hospital stay one Follow-up telephone interview will be carried out at 3 months after first application of the study drug.
    A patient questionnaire on cognition, quality of life, posttraumatic anxiety will be carried out.
    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 Decision2013-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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