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    Summary
    EudraCT Number:2018-001763-23
    Sponsor's Protocol Code Number:2018-001763-23
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001763-23
    A.3Full title of the trial
    Treatment of headaches post-ECT with oxygen therapy; a proof of concept study
    Behandeling van hoofdpijnklachten post-ECT middels zuurstoftherapie; een proof of concept studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with oxygen of headaches after electroshock therapy
    Behandeling van hoofdpijnklachten na elektroshocktherapie met zuurstof
    A.4.1Sponsor's protocol code number2018-001763-23
    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 SponsorReinier van Arkel
    B.1.3.4CountryNetherlands
    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 supportReinier van Arkel
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReinier van Arkel
    B.5.2Functional name of contact pointGijs Hendriks
    B.5.3 Address:
    B.5.3.1Street AddressBethaniestraat 2
    B.5.3.2Town/ cityDen Bosch
    B.5.3.3Post code5211LJ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031646150456
    B.5.6E-mailgtjmhendriks@gmail.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 Zuurstof medicinaal vloeibaar AIR LIQUIDE, medicinaal gas, cryogeen 100% v/v
    D.2.1.1.2Name of the Marketing Authorisation holderAIR LIQUIDE
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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
    Headaches occuring after electro conculsion therapy.
    Hoofdpijn die optreed na elektroconvulsietherapie.
    E.1.1.1Medical condition in easily understood language
    Headaches occuring after electro conculsion therapy.
    Hoofdpijn die optreed na elektroconvulsietherapy.
    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
    Reduction of headache complaints after electro convulsion therapy. Effect of treatment is defined as a reduction of headache on the VRS (verbal rating scale), from 2 or 3 to equal or less than 1.
    Verminderen van hoofdpijnklcahten die optreden na ECT-behandeling.
    Een behandeleffect wordt gedefinieerd als een vermindering van de hoofdpijn op de VRS (verbal rating scale) van 2 of 3 naar minder dan of gelijk aan 1.
    E.2.2Secondary objectives of the trial
    Time untill the treatment effect. It is expected that oxygen therapy will result in an imediate reduction of headache, as it is the case in treatment of cluster headache.

    Duration of treatment effect. It is expected that reduction of headache will last for at least 2 hours.
    Tijdsduur tot een behandeleffect optreed. Er wordt verwacht dat het effect van zuurstoftoediening of de hoofdpijnklachten direct optreed, zoals dat ook bij de behandeling van clusterhoofdpijn het geval is.

    Duur van het behandeleffect. Het wordt verwacht dat de vermindering van hoofdpijnklachten ten minste twee uur aanhoudt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age older than 18
    Indication for ECT for psychiatric illness.
    Hospitalized in the department ZPO of the Reinier van Arkel groep
    Leeftijd ouder dan 18 jaar
    Indicatie voor ECT behandeling voor psychiatrische klachten.
    Klinisch opgenomen binnen het Centrum voor ouderen en ziekenhuispsychiatrie van Reinier van Arkel, locatie Jeroen Bosch ziekenhuis.
    E.4Principal exclusion criteria
    COPD
    Current use of bleomycine, or in the past 12 months
    Patients with a custody measure
    Patients who are mentally incompetent regarding the decision of participation in the study, or undergo trial operations
    Patients who suffer from panic attacks
    Patients with a VRS-score equal or less than 1 after ECT
    Patients with a VRS-score more than 1 before ECT
    COPD
    Huidig gebruik van bleomycine, of in de afgelopen 12 maanden
    Patiënten met IBS of voorlopige Rechterlijke Machtiging.
    Wilsonbekwaamheid ten aanzien van het besluit voor deelname aan de studie, of het ondergaan van studiehandelingen.
    Patienten die lijden aan paniekaanvallen
    Patienten met een VRS-score kleiner of gelijk aan 1, na ECT
    Patienten met een VRS-score groter dan 1 vóór ECT
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of headache from a score of 2 or 3 on the verbal rating scale (VRS) to equal or less than 1..
    Vermindering van hoofdpijnklcahten van 2 of 3, naar minder dan of gelijk aan 1 op de verbal rating scale (VRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment effect will be measured after ECT, after oxygen therapy and after 60 and 120 minutes after oxygen therapy.
    Behandeleffect zal worden gemeten na ECT, direct na zuurstofbehandeling en na 60 en 120 minuten na zuurstofbehandeling.
    E.5.2Secondary end point(s)
    not applicable
    niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet van toepassing
    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 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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 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.4.1In the member state68
    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)
    If oxygen therapy is proved to be save, and helpfull in the reduction of headache after ECT for that particular patient, oxygen therapy can be continued after ending participation. Each subject can participate maximum three times in this trial.
    Als is aangetoond dat zuurstoftherapie veilig en nuttig is bij het verminderen van hoofdpijn na ECT voor die specifieke patiënt, kan de zuurstoftherapie worden voortgezet na het beëindigen van de deelname. Elke patient kan maximaal drie keer deelnemen aan deze studie.
    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 Decision2018-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-27
    P. End of Trial
    P.End of Trial StatusOngoing
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