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    Summary
    EudraCT Number:2021-000592-36
    Sponsor's Protocol Code Number:CGRPAMS03
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2023-01-13
    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 - PEI
    A.2EudraCT number2021-000592-36
    A.3Full title of the trial
    Calcitonin Gene-Related Peptide Receptor Antagonists for Prevention of Acute Mountain Sickness
    Prävention der akuten Bergkrankheit durch Calcitonin Gene-Related Peptide Rezeptor Antagonisten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CGRPR Antagonists and Acute Mountain Sickness
    CGRPR Antagonisten und akute Bergkrankheit
    A.4.1Sponsor's protocol code numberCGRPAMS03
    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 SponsorUniversitätsklinikum Essen
    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 supportKlinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportStiftung Universitätsmedizin Essen
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportWilderness Medical Society
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
    B.5.2Functional name of contact pointSekretariat Anästhesiologie
    B.5.3 Address:
    B.5.3.1Street AddressHufelandstraße 55
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45147
    B.5.3.4CountryGermany
    B.5.4Telephone number00492017231401
    B.5.5Fax number00492017235949
    B.5.6E-mailkai-studienzentrale@uk-essen.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 Aimovig
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameErenumab
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Mountain Sickness (AMS) is a constellation of symptoms (headache, anorexia, nausea, vomiting, lightheadedness, and fatigue) occuring in unacclimatized mountaineers ascending too fast, too high
    Akute Bergkrankheit besteht aus Kopfschmerz, Appetitlosigkeit, Übelkeit, Erbrechen, Benommenheit und Müdigkeit und tritt bei nichtakklimatisierten Bergsteigern auf, die zu schnell in zu große Höhe aufsteigen
    E.1.1.1Medical condition in easily understood language
    Acute Mountain Sickness (AMS) is a constellation of symptomes (headache, nausea, lightheadedness, fatigue, and poor sleep) occuring in unacclimatized mountaineers ascending too fast, too high
    Akute Bergkrankheit besteht aus Kopfschmerz, Übelkeit, Verwirrtheit, Müdigkeit und Schlaflosigkeit und tritt bei nichtakklimatisierten Bergsteigern auf, die zu schnell in zu große Höhe aufsteigen
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020045
    E.1.2Term High altitude illness
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does Erenumab reduce the severity of AMS after a 12-hours exposure to normobaric hypoxia at an oxygen concentration of 12% (corresponding to an altitude of 4500 m)?
    Reduziert Erenumab den Schweregrad der akuten Bergkrankheit nach 12 Stunden Exposition gegenüber normobarer Hypoxie mit einer Sauerstoffkonzentration von 12 % (entspricht einer Höhe von 4500 m)?
    E.2.2Secondary objectives of the trial
    Does Erenumab reduce the incidence of AMS after a 12-hours exposure to normobaric hypoxia at an oxygen concentration of 12% (corresponding to an altitude of 4500 m)?
    Reduziert Erenumab die Inzidenz der akuten Bergkrankheit nach 12 Stunden Exposition gegenüber normobarer Hypoxie mit einer Sauerstoffkonzentration von 12 % (entspricht einer Höhe von 4500 m)?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-60 years
    - Good physical condition
    - No relevant pathologies revealed upon the pre-examination prior to the study
    - Written informed consent to participate in the study
    - Permanent residency below 1000 m
    - Males and females are included without prioritization
    - More than 3 weeks since vaccination against or full recovery from SARS-CoV2 infection
    - Negative serum or urine pregnancy test in women of childbearing potential if pregnancy cannot be ruled out
    - Alter: 18-60 Jahre
    - guter Gesundheitszustand
    - keine klinisch relevanten pathologischen Befunde in der Voruntersuchung
    - freiwillig unterzeichnete Einverständniserklärung nach vollstänidger Information über die Studie
    - wohnhaft unter 1000 m
    - Männer und Frauen werden gleichermaßen berücksichtigt
    - Seit mindestens 3 Wochen vollständige Impfung gegen SARS-CoV2 oder durchgemachte Infektion
    - Negativer Serum oder Urin Schwangerschaftstest bei Frauen im gebärfähigen Alter, wenn eine Schwangerschaft nicht ausgeschlossen werden kann
    E.4Principal exclusion criteria
    - Intolerance against erenuma or any drug component
    - Acute and chronic lung diseases
    - Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
    - Conventional systolic blood pressure ≥150 mmHg and conventional diastolic blood pressure ≥95 mmHg (average of two measurements) in untreated or treated subjects
    - Chronic headache / migraine
    - Diabetes mellitus
    - Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
    - Alcohol (>30 g/d) or drug abuse
    - Obesity (Body Mass Index >30)
    - Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders, Parkinson disease, pheochromocytoma)
    - Sojourn >2000 m within the last 8 weeks before the 1st study day
    - Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti-coagulants)
    - Blood donation within the last 2 month before the 1st study day
    - Pregnant or nursing women
    - Participation in other clinical trials
    - Unverträglichkeit/ Allergie gegen Erenumab oder andere Medikamentenbestandteile
    - Akute oder chronische Lungenerkrankung
    - andere kardiovaskuläre Vorerkrankungen als arterielle Hypertonie (KHK, Herzinsuffizienz, Vorhofflimmern, pAVK)
    - systolischer Blutdruck ≥ 150 mmHg und diastolischer Blutdruck ≥ 95 mmHg (Durchschnitt aus 2 Messungen) in behandelten oder unbehandelten Probanden
    - chronische Kopfschmerzen/ Migräne
    - Diabetes mellitus
    - Rauchen (>6 Zigaretten/ Tag oder äquivalente Nikotinsubstitution)
    - Alkohol (>30 g/d), Drogenkonsum
    - Übergewicht (Body Mass Index > 30)
    - andere, relevante Erkrankungen (z.B. Leber, Nieren, Schilddrüse, M. Parkinson, Phäochromozytom)
    - Aufenthalt > 2000 m innerhalb der letzten 8 Wochen vor Untersuchungsbeginn
    - Medikamenteneinnahme innerhalb der letzten 2 Monate, welche die Datenqualität oder die Probandensicherheit beeinflussen könnte
    - Blutspende innerhalb der letzten 2 Monate vor Untersuchungsbeginn
    - Schwangerschaft oder Stillzeit
    - Teilnahme an anderen klinischen Studien
    E.5 End points
    E.5.1Primary end point(s)
    Severity of AMS measured by the means of the Lake Louise Score
    Schweregrad der akuten Bergkrankheit gemessen anhand des Lake Louise Scores
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-hours after beginning of exposure to normobaric hypoxia at an oxygen concentration of 12%
    12 Stunden nach Beginn Exposition gegenüber normobarer Hypoxie mit einer Sauerstoffkonzentration von 12 %
    E.5.2Secondary end point(s)
    Incidence of AMS
    Inzidenz der akuten Bergkrankheit
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-hours after beginning of exposure to normobaric hypoxia at an oxygen concentration of 12%
    12 Stunden nach Beginn Exposition gegenüber normobarer Hypoxie mit einer Sauerstoffkonzentration von 12 %
    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 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 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 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 years1
    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: 30
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state30
    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 termination of the trial (i.e. 30 days after injection of the study drugs) we will contact the subjects by phone to evaluate the general state of health and potential side-effects.
    Nach Abschluss der Studie (d.h. 30 Tage nach Applikation des Studienmedikaments) werden die Probanden telefonisch kontaktiert, um den Allgemeinzustand und mögliche Nebenwirkungen zu evaluieren.
    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 Decision2023-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2025-01-30
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