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    The EU Clinical Trials Register currently displays   34378   clinical trials with a EudraCT protocol, of which   5573   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-003648-59
    Sponsor's Protocol Code Number:CH1.0
    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:2012-09-10
    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 number2012-003648-59
    A.3Full title of the trial
    Oxygen treatment for cluster headache attacks at different flow rates. A double-blind, randomized, cross-over design study.
    Zuurstoftherapie met verschillende stroomsnelheden voor clusterhoofdpijn aanvallen. Een dubbelblinde, gerandomiseerde, cross-over design studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxygen treatment for cluster headache attacks at different flow rates. A double-blind, randomized, cross-over design study.
    Zuurstoftherapie met verschillende stroomsnelheden voor clusterhoofdpijn aanvallen. Een dubbelblinde, gerandomiseerde, cross-over design studie.
    A.3.2Name or abbreviated title of the trial where available
    CLATOXYT (CLuster headache ATtacks OXYgen Treatment)
    CLATOXYT (Clusterhoofdpijn en Zuurstoftherapie)
    A.4.1Sponsor's protocol code numberCH1.0
    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 SponsorDept. of Neurology, Atrium Medical Centre
    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 supportWestfalen Medical BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Neurology, Atrium Medical Centre
    B.5.2Functional name of contact pointDanielle Haane
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 4446
    B.5.3.2Town/ cityHeerlen
    B.5.3.3Post code6401 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031455766700
    B.5.6E-mailclusterhoofdpijn@atriummc.nl
    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 Oxygen, compressed
    D.2.1.1.2Name of the Marketing Authorisation holderWestfalen Medical BV
    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.3.1Product nameOxygen, compressed
    D.3.2Product code O2
    D.3.4Pharmaceutical form Medicinal gas, compressed
    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
    To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks.
    Bestudering of er een verschil is in pijnstillend effect tussen zuurstof gegeven met een stroomsnelheid van 7 L/min versus 12 L/min bij de acute behandeling van clusterhoofdpijn aanvallen.
    E.1.1.1Medical condition in easily understood language
    To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks.
    Bestudering of er een verschil is in pijnstillend effect tussen zuurstof gegeven met een stroomsnelheid van 7 L/min versus 12 L/min bij de acute behandeling van clusterhoofdpijn aanvallen.
    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
    To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks.
    Bestudering of er een verschil is in pijnstillend effect tussen zuurstof gegeven met een stroomsnelheid van 7 L/min versus 12 L/min bij de acute behandeling van clusterhoofdpijn aanvallen.
    E.2.2Secondary objectives of the trial
    - Identifying subgroups in which oxygen at flow rates of 7 L/min or 12 L/min is more effective.
    - To determine whether the rebound effect known to occur in oxygen treatment is more frequently observed in one of the different flow rates or whether this is an effect independent from the flow rates used.
    - To note any potential side-effects of oxygen treatment, and if observed, determine if they occur more in either 7 L/min or 12 L/min.
    - To determine if the efficacy of oxygen treatment stays constant after several treated attacks.
    - Patiënten karakteristieken onderscheiden die het effect van verschillende zuurstof stroomsnelheden kunnen voorspellen. Dit zou de neuroloog kunnen helpen om te bepalen bij welke patiënten 12 liter per minuut en bij welke 7 liter per minuut de voorkeur heeft;
    - Bepaling of het rebound effect bij zuurstoftherapie meer voorkomt bij een van de zuurstof stroomsnelheden;
    - Bepaling van mogelijke bijwerkingen van zuurstoftherapie en of deze vaker voorkomen bij een stroomsnelheid van 7 liter per minuut of 12 liter per minuut;
    - Bepaling of de effectiviteit van zuurstoftherapie gelijk blijft na de behandeling van meerdere clusterhoofdpijn aanvallen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All newly diagnosed cluster headache patients of at least 18 years of age and known cluster headache patients of at least 18 years of age who are naïve to oxygen treatment.
    Clusterhoofdpijn patiënten van 18 jaar en ouder die nog niet eerder zuurstof gebruikten.
    E.4Principal exclusion criteria
    - All patients who used oxygen in the past.
    - Pregnancy or lactation.
    - COPD and other contraindications for oxygen therapy, as determined by the patients’ physicians.
    - Secondary cluster headache. Patients might be included before imaging is conducted. If so, they will be excluded afterwards when they are diagnosed as secondary cluster headache.
    - Other primary or secondary headache diagnoses or other distracting painful conditions which could interfere with the patient’s pain perception.
    - Incapacitation to understand and sign for informed consent.
    - Patients living outside a designated insurance zone, as costs of the adapted oxygen tanks will not be covered elsewhere.
    - Alle patiënten die in het verleden zuurstof gebruikten.
    - Zwangerschap of geven van borstvoeding.
    - COPD en andere contraïndicaties voor zuurstofbehandeling, zoals vastgesteld door de behandelend arts van de patiënt.
    - Secundaire clusterhoofdpijn.
    - Andere primaire of secundaire hoofdpijn diagnosen of andere pijnlijke aandoeningen die kunnen interfereren met de pijnperceptie van de patiënt.
    - Onmogelijkheid om het informed consent te begrijpen en hiervoor te tekenen.
    - Patiënten die buiten de aangegeven verzekeringszone wonen.
    E.5 End points
    E.5.1Primary end point(s)
    The main end point of the study will be the difference in VAS-scores before and after treatment.
    Primaire uitkomstmaat is verschil in VAS-score voor en na zuurstofbehandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 minutes after start of oxygen treatment
    15 minuten na start van zuurstofbehandeling
    E.5.2Secondary end point(s)
    The secondary endpoint will be the percentage of attacks treated successfully. An attack treated successfully is defined as achievement of a painfree state or as a drop in VAS-score of over 50% within 15 minutes.
    Secundaire uitkomstmaat is percentage succesvol behandelde clusterhoofdpijn aanvallen, gedefinieerd als een daling in de VAS-score van > 50% binnen 15 minuten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 minutes after start of oxygen treatment
    15 minuten na start van zuurstofbehandeling
    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 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) 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 No
    E.8.1.6Cross over Yes
    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
    Andere zuurstof stroomsnelheid (7 versus 12 L/min)
    Other oxygen flow rate (7 versus 12 L/min)
    E.8.2.4Number of treatment arms in the trial2
    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
    Completed treatment of 100 patients
    Voltooide behandeling van 100 patiënten
    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 months
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 2012-09-10. 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 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 state100
    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
    Geen
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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