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    Summary
    EudraCT Number:2021-000732-54
    Sponsor's Protocol Code Number:NCH-201803
    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:2021-07-09
    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 number2021-000732-54
    A.3Full title of the trial
    FINISHER - Fight Inflammation to Improve outcome after aneurysmal Subarachnoid Hemorrhage
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FINISHER - Anti-inflammatory therapy after aneurysmal subarachnoid haemorrhage to improve treatment outcome
    Entzündungshemmende Therapie nach aneurysmatischer Subarachnoidalblutung zur Verbesserung des Behandlungs-ergebnisses
    A.3.2Name or abbreviated title of the trial where available
    FINISHER
    FINISHER
    A.4.1Sponsor's protocol code numberNCH-201803
    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 SponsorRheinische Friedrich-Wilhelms-Universität Bonn
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStudienzentrale Studienzentrum Bonn
    B.5.2Functional name of contact pointVerena Proß
    B.5.3 Address:
    B.5.3.1Street AddressVenusberg-Campus 1
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53127
    B.5.3.4CountryGermany
    B.5.4Telephone number+4922828713917
    B.5.5Fax number+4922828716039
    B.5.6E-mailverena.pross@ukbonn.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 Dexa inject JENAPHARM
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    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 injection
    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 INNDexamethasone
    D.3.9.3Other descriptive nameDEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EUR.
    D.3.9.4EV Substance CodeSUB176825
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    aneurysmal subarachnoid hemorrhage
    E.1.1.1Medical condition in easily understood language
    Bleeding into the subarachnoidal area of the brain
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042316
    E.1.2Term Subarachnoid haemorrhage
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To analyze impact on outcome of an anti-inflammatory treatment with dexamethasone in patients with acute aneurysmal subarachnoid hem-orrhage with or without an initial inflammatory sig-nature in peripheral blood compared to placebo
    E.2.2Secondary objectives of the trial
    1. Analysis of improvement in survival rate
    2. Analysis of improvement in recovery time in patients receiving dexamethasonen after aSAH
    3. Analysis of delayed ischemic neurological deficit (DIND)
    4. Analysis of symptomatic vasospasm
    5. Analysis of inflammation parameters
    6. Evaluation of quality of life (QoL)
    7. Safety analysis of dexamethasone for treat-ment in patients suffering from SAH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects, equal or older than 18 years old
    2. Written consent to participate in the study by patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the prinicipal investigator is possible)
    3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion
    E.4Principal exclusion criteria
    1. SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malfor-mation (AVM), fistula, dissection)
    2. Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study
    3. Patients with obvious evidence of irreparable brainstem or thalamic injury
    4. Patients with foreseeable difficulties to attend follow-ups adequately
    5. Subjects with a physical or psychiatric condi-tion which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s par-ticipation in this clinical trial
    6. Current positive pregnancy test (e.g. ß-HCG test in serum)
    7. Known history of hypersensitivity to the inves-tigational drug or to drugs with a similar chemical structure
    8. Severe infectious diseases (in discretion of the local investigator by clinical and laboratory pa-rameters e.g. CRP, PCT, WBC, IL-6)
    9. Known angle-closure or open angle glaucoma
    10. Known ulceration in the gastro-intestinal tract
    11. History of gastro-intestinal bleeding
    12. Long-term treatment with corticosteroids prior SAH
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after the sub-arachnoid hemorrhage - dichotomized in “favourable (mRS 0-3) versus “unfavourable“ (mRS 4-6) out-come
    E.5.2Secondary end point(s)
    Comparison between both treatment arms:
    1. a) Analysis of mortality at 7, 90 and 365 days after a SAH
    b) Comparison of time of death in patients
    2. Length of ICU stay and hospitalization after aSAH
    3. Delayed ischemic neurological deficit (DIND)
    4. Symptomatic vasospasm measured by transcranial doppler/ computed tomography
    scans/ MR angiography/ angiography
    5. Level of inflammation parameters such as CRP, PCT, WBC, IL-6, IL-1ß in serum
    6. Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH
    7. Analysis of AEs by number, severity, relation-ship
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analysis of mortality at 7, 90 and 365 days after a SAH
    Time of death in patients = upon occurrence
    Length of ICU stay and hospitalization after aSAH = upon occurrence
    Delayed ischemic neurological deficit (DIND) = upon occurrence
    Symptomatic vasospasm measured by tran-scranial doppler/ computed tomography
    scans/ MR angiography/ angiography = Visit 1, 3, 4-22, 25
    Inflammation parameters such as CRP, PCT, WBC, IL-6, IL-1ß in serum = Visit 1, 3, 4-22, 23, 25
    SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH
    AEs by number, severity, relationship = every Visit except for Visit 1 and 26
    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 No
    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 concerned14
    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 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 Subject 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 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: 184
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-07-09. Yes
    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
    If subject is incapable of giving informed consent personally, informed consent will be obtained by next of kin or consultant physician.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state334
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Stiftung Deutsche Schlaganfall-Hilfe
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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