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    Summary
    EudraCT Number:2018-002224-17
    Sponsor's Protocol Code Number:201805GON
    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:2018-12-20
    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 number2018-002224-17
    A.3Full title of the trial
    GON-injection for a sooner and better treatment of cluster headache: a double-blind randomized controlled trial
    GON-injectie voor een snellere en betere behandeling van clusterhoofdpijn: een dubbelblind gerandomiseerde placebo-gecontroleerde studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Greater occipital nerve block for a sooner en and better treatment of cluster headache
    Zenuwblokkade van de grote achterhoofdszenuw voor een snellere en betere behandeling van clusterhoofdpijn
    A.3.2Name or abbreviated title of the trial where available
    CHIANTI
    A.4.1Sponsor's protocol code number201805GON
    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 SponsorLeids Universitair Medisch Centrum
    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 supportHersenstichting
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportInnovatiefonds zorgverzekeraars
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeids Universitair Medisch Centrum
    B.5.2Functional name of contact pointHoofdpijnonderzoek
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.6E-mailhoofdpijnonderzoek@lumc.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 Depo-Medrol 40 mg/ml, suspensie voor injectie
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameMethylprednisolonacetaat
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    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 placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic cluster headache
    E.1.1.1Medical condition in easily understood language
    Episodic cluster headache
    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 provide a definitive answer regarding the efficacy of GON-injection as first-line prophylactic therapy in episodic cluster headache, by showing that GON-injection decreases the mean total dose of verapamil needed during the treatment of a cluster episode in episodic cluster headache.
    E.2.2Secondary objectives of the trial
    To Show that the addition of GON-injection leads to
    - faster attack-freedom (7 consecutive days without attacks) than the current standard treatment with verapamil only.
    - less side-effects than the current standard treatment with only verapamil.
    - a decrease in attack frequency, severity and duration of attacks (and thus a decrease in the use of attack medication) compared to the current standard treatment with only verapamil.
    To learn how long the beneficial effects of GON-injection will last.
    To show that GON-injection will lead to higher patient satisfaction scores, compared to the current standard treatment with only verapamil.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders – third edition beta, ICHD-3b
    - Patients have to be aged 18-65 years
    - Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
    - Patients need to have a mean of more than 1 attack per day in the 3 days preceding inclusion.
    - Patients should be in their cluster period for shorter than 4 weeks before inclusion.
    E.4Principal exclusion criteria
    - A contraindication for treatment with steroids or verapamil
    - The use of anticoagulants or known bleeding disorder.
    - Use of any prophylactic medication for cluster headache
    - Patients with a history of other primary headache who are currently using prophylactic medication for this headache
    - Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the decrease in mean total dose of verapamil used per day during the study period
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve weeks
    E.5.2Secondary end point(s)
    Secondary endpoints:
    1. Median number of days to remission (7 consecutive days without attack)
    2. Mean number of attacks per day
    3. Peak dose verapamil
    4. Premature termination of study due to need for prophylactic escape medication

    Tertiary endpoints
    5. The total use of attack medication
    6. Mean number, severity (1-10) and duration of attack per day.
    7. Percentage of patients that are attack-free at days 7, 14 and 28
    8. Occurrence of ‘non-cluster’ headache (number of days and mean intensity per affected day)
    9. Adverse events
    10. Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS)
    11. Satisfaction score (7 point scale, higher scores are better)
    12. Would the patient recommend this treatment to others?
    13. What treatment does the patient think he/she received (placebo/GON/uncertain)?
    14. What treatment do the investigators think the patient has had?
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every day in in the complete 12-week study period
    - 1-6, 8, 9 and 11

    At the end of each of the three 4-week timeperiods
    - 5, 6, 8

    Days 7, 14, and 28
    - 7, 10

    Days 2, 28 and at the end of the 12-week study period
    - 12, 13 and 14
    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) 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 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 concerned6
    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
    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: 80
    F.1.3Elderly (>=65 years) No
    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 2018-12-20. 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 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 the 12-week study period, participants will continue the standard treatment with verapamil (including further titration if needed with adequate ECG evaluation) and, if necessary, treatment with lithium or prednisone.
    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 Decision2018-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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