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    Summary
    EudraCT Number:2018-003382-34
    Sponsor's Protocol Code Number:NeuroPharm_EPOCH
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-30
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-003382-34
    A.3Full title of the trial
    Prophylactic effects of psilocybin on chronic cluster headache: an open-label clinical trial and neuroimaging study.
    Forebyggende effekter af psilocybin på Hortons hovedpine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylactic effects of psilocybin on chronic cluster headache: an open-label clinical trial and neuroimaging study.
    Forebyggende effekter af psilocybin på Hortons hovedpine.
    A.4.1Sponsor's protocol code numberNeuroPharm_EPOCH
    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 SponsorNeuroPharm
    B.1.3.4CountryDenmark
    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 supportAugustinusfonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNeuroPharm
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroPharm
    B.5.2Functional name of contact pointNeuroPharm
    B.5.3 Address:
    B.5.3.1Street AddressCopenhagen University Hospital - Rigshospitalet, section 6931, Blegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535456720
    B.5.5Fax number4535456713
    B.5.6E-mailgmk@nru.dk
    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 No
    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 namePsilocybin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPSILOCYBINE
    D.3.9.1CAS number 520-52-5
    D.3.9.4EV Substance CodeSUB10158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.14
    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
    Chronic cluster headache.
    Kronisk Hortons (klyngehovedpine) hovedpine
    E.1.1.1Medical condition in easily understood language
    Chronic cluster headache.
    Kronisk Hortons (klyngehovedpine) hovedpine
    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 LLT
    E.1.2Classification code 10056941
    E.1.2Term MRI brain
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009698
    E.1.2Term Cluster headaches
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020397
    E.1.2Term Horton's headache
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the present open-label trial is to evaluate the effect of psilocybin on chronic cluster headache (i.e., headache frequency).
    Hovedformålet med projektet er at evaluere effekten af psilocybin på hovedpinefrekvensen i kronisk klyngehovedpine (Hortons hovedpine).
    E.2.2Secondary objectives of the trial
    Additional objectives are to 1) evaluate changes in brain function and correlations with potential clinical effects, 2) evaluate the extent to which plasma psilocin levels correlate with clinical effects.
    Yderligere formål er at 1) evaluere om der er forandringer i hjernefunktion, og om forandringer korrelerer med potentielle kliniske effekter, 2) evaluere om plasma psilocinniveauer korrelerer med kliniske effekter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age between 18 and 65
    •A diagnosis of chronic cluster headache according to IHCD-III.
    •Ability to separate cluster headache attacks from other types of headache.
    •A history of at least 4 attacks/week in the last 4 weeks before inclusion
    •Alder mellem 18 og 65 år
    •En diagnose for kronisk Hortons hovedpine ifølge IHCD-III.
    •Evne til at adskille Hortons hovedpine anfald fra andre typer hovedpine.
    •Mindst 4 anfald/uge i de sidste 4 uger inden inklusion.
    E.4Principal exclusion criteria
    • A history of using a serotonergic hallucinogen for CH.
    • Participation in any clinical trials within 30 days preceding study enrollment.
    • Use of other prophylactic CH medication within the last two weeks.

    Current use of drugs suspected to interfere with treatment (e.g. antipsychotic medication).
    •Current use of drugs suspected to be hazardous in combination with psilocybin.
    • Presence of other trigeminal autonomic cephalalgias.
    • Known hypersensitivity/allergy to multiple drugs (including psilocybin).
    • A history or presence of any medical and psychiatric condition that might render patient unsuitable for participation.
    • Present or previous manic or psychotic disorder or critical psychiatric disorder.
    • Current drug or alcohol abuse.
    • MRI Contraindications.
    • Pregnancy or breastfeeding .
    • Not using safe contraception (if fertile woman).
    • Stroke (<1 year from inclusion).
    • Myocardial infarction (<1 year from inclusion).
    • Hypertension (> 140/90 mmHg at inclusion).
    • Clinically significant arrhythmia (<1 year from inclusion).
    • Tidligere brug af serotonerge hallucinogener for Hortons hovedpine.
    • Deltagelse i et klinisk forsøg inden for 30 dage forud for inklusion.
    • Brug af anden profylaktisk medicin inden for forsøgsperioden.
    • Nuværende brug af stoffer der formodes at kunne interagere med psilocybin behandling (fx antipsykotisk medicin).
    • Nuværende brug af stoffer der formodes at være farlige i kombination med psilocybin.
    • Tilstedeværelse af andre trigeminale autonome cephalalgier.
    • Kendt overfølsomhed / allergi over for flere lægemidler (herunder psilocybin).
    • Kendt med eller tilstedeværelse af enhver medicinsk og psykiatrisk tilstand, der kan gøre patienten uegnet til deltagelse.
    • Nuværende eller tidligere manisk eller psykotisk lidelse eller kritisk psykiatrisk lidelse.
    • Nuværende stof eller alkohol misbrug.
    • Kontraindikationer for MR-scanning
    • Graviditet eller ammende.
    • Brug af ikke sikker kontraception (hvis kvinde)
    • Apopleksi (<1 år fra inklusion)
    • Myokardieinfarkt (<1 år fra inklusion)
    • Hypertension (> 140/90 mmHg ved inklusion)
    • Klinisk betydende arytmi (<1 år fra inklusion).
    E.5 End points
    E.5.1Primary end point(s)
    1.Change in headache frequency in number of attacks/week.
    2.Resting state FC fMRI analyses, including hypothalamic FC, comparing baseline and rescan, comparison with healthy control sample, and evaluation of correlation between headache frequency changes and FC changes
    1.Ændring i hovedpinefrekvens (anfald/uge)
    2.Resting state funktionel konnektivitetsanalyser (FC), inkl. hypothalamisk FC, sammenligning af baseline og rescan, med raske kontroller og evaluering af korrelation mellem hovedpinefrekvens og FC forandringer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.In week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline.
    2.At baseline and at MRI rescan.
    1.Uge 6-10 (sidste fire uger efter psilocybin) vs fire ugers baseline.
    2.Ved baseline og ved rescan.
    E.5.2Secondary end point(s)
    1.Proportion of patients with a 50% reduction in headache frequency in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline.
    2.Change in average headache intensity in number of attacks/week in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline.
    3.Number of attacks requiring acute therapy in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline.
    4.Proportion of patients experiencing serious side effects.
    5.Proportion of patients with remission lasting more than 1 month.
    6.Duration of induced remission (number of weeks)
    7.Proportion of patients who changes from CCH to eCH.
    8.Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36) in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline
    9.Proportion of patients that prefers to continue with psilocybin if this was an option or want to return to usual prophylactics
    10.Changes in mood (POMS), perceived stress (PSS), sleep quality (PSQI) and depressive symptoms (MDI) pre-psilocybin (week 1 and 5) vs post-psilocybin (week six and eight).
    1. Andel af patienter med 50% reduktion i hovedpinefrekvens i uge 6-10, dvs. de fire uger efter den sidste psilocybindosis sammenlignet med fire ugers baseline.
    2. Ændring i gennemsnitlig hovedpineintensitet i antal anfald per ​​uge i uge 6-10, dvs. de fire uger efter den sidste psilocybindosis sammenlignet med fire ugers baseline.
    3. Antal anfald, der kræver akut behandling i uge 6-10, dvs. de fire uger efter den sidste dosis psilocybin sammenlignet med fire ugers baseline.
    4.Andel af patienter, der oplever alvorlige bivirkninger.
    5. Andel patienter med remission, der varer mere end 1 måned.
    6. Varighed af induceret remission (antal uger)
    7. Andel af patienter, der skifter fra CCH til eCH.
    8. Livskvalitet vurderet ved hjælp af spørgeskemaer: 36-item short-form health survey (SF-36) i uge 6-10, dvs. de fire uger efter den sidste dosis psilocybin sammenlignet med den fire ugers baseline
    9. Andel af patienter, der foretrækker at fortsætte med psilocybin, hvis dette var en mulighed eller ønsker at vende tilbage til almindelig forebyggende behandling
    10. Ændringer i humør (POMS), opfattet stress (PSS), søvnkvalitet (PSQI) og depressive symptomer (MDI) pre-psilocybin (uge 1 og 5) vs post-psilocybin (uge seks og otte).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3,8. week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline.
    4. All study.
    5-7,9. All study. Data collection at 3, 6 and 12 months.
    10. Pre psilocybin Week 1 and 5 vs post-psilocybin Week six and eight.

    1-3,8. uge 6-10, dvs. de fire uger efter den sidste psilocybindosis sammenlignet med fire ugers baseline.
    4. Alle undersøgelser.
    5-7,9. Alle undersøgelser. Dataindsamling efter 3, 6 og 12 måneder.
    10. Pre psilocybin Uge 1 og 5 kontra post-psilocybin Uge seks og otte.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Changes in brain function as measured with MRI.
    Forandringer i hjernefunktion målt med MRI.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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: 20
    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 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 state20
    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)
    No particular arrangements.
    Ingen særlige hensyn.
    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 Decision2019-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-01
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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