Phase
Condition
Migraine (Pediatric)
Chronic Pain
Migraine And Cluster Headaches
Treatment
Eptinezumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3)classification with a history of cCH of at least 12 months prior to the ScreeningVisit.
The participant has a medical history of onset of cluster headache at ≤50 years ofage.
The participant has an adequately documented record of previous abortive,transitional and preventive medication use for cCH, for at least 12 months prior tothe Screening Visit.
The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).
Exclusion
Exclusion Criteria:
The participant has experienced failure on a previous treatment targeting thecalcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies [mAbs] and gepants).
The participant has confounding and clinically significant pain syndromes (forexample, fibromyalgia, complex regional pain syndrome).
The participant has a history or diagnosis of chronic tension-type headache, hypnicheadache, hemicrania continua, new daily persistent headache, chronic migraine orunusual migraine subtypes such as hemiplegic migraine (sporadic and familial),recurrent painful ophthalmoplegic neuropathy, migraine with neurologicalaccompaniments that are not typical of migraine aura (diplopia, alteredconsciousness, or longer than 1 hour).
Participants with a lifetime history of psychosis, bipolar mania, or dementia.Participants with other psychiatric conditions whose symptoms are not controlled orwho have not been adequately treated for a minimum of 6 months prior to ScreeningVisit.
The participant has attempted suicide or is, at Screening Visit, at significant riskof suicide.
The participant has a history of clinically significant cardiovascular disease,including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonaryembolism).
Other inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Rigshospitalet Glostrup
Glostrup, Hovedstaden 2600
DenmarkSite Not Available
Hospitalsenhed Midt og Regionshospitalet Viborg
Viborg, Midtjylland 8800
DenmarkSite Not Available
Terveystalo Ruoholahti
Helsinki, Southern Finland 00180
FinlandSite Not Available
Terveystalo Turku Pulssi
Turku, Western Finland 20100
FinlandSite Not Available
Hôpital Cimiez
Nice Cedex 1, Côte-d'Or 91179 - 06003
FranceSite Not Available
Hôpital Roger Salengro
Lille, Nord 59037
FranceSite Not Available
Hôpital de la Timone
Marseille Cedex 5, Provence Alpes Cote d'Azur 13005
FranceSite Not Available
Hôpital Pierre Wertheimer
Bron, Rhône 69677
FranceSite Not Available
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, Rhône 42055
FranceSite Not Available
Hôpital Lariboisière
Paris, Île-de-France 75010
FranceSite Not Available
Kopfschmerzzentrum Frankfurt
Frankfurt/ Main, Hessen 65929
GermanySite Not Available
Charité Campus Mitte
Berlin, 10117
GermanySite Not Available
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
Milano, Milan 20133
ItalySite Not Available
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
Rome, Roma 00163
ItalySite Not Available
IRCCS Istituto Delle Scienze Neurologiche di Bologna
Bologna, 40123
ItalySite Not Available
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
Pavia, 27100
ItalySite Not Available
Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
Turin, 10126
ItalySite Not Available
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland 6532 SZ
NetherlandsSite Not Available
Brain Research Center - Amsterdam
Amsterdam, Noord-Holland 1081 GN
NetherlandsSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainSite Not Available
Hospital Clínico Universitario de Valladolid
Valladolid, 47010
SpainSite Not Available
Hospital Clínico Universitario de Valencia
València, 46010
SpainSite Not Available
The Walton Centre NHS Foundation Trust
Liverpool, England L9 7LJ
United KingdomSite Not Available
Walton Centre NHS Foundation Trust
Liverpool, England L9 7LJ
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, England SE5 9RS
United KingdomSite Not Available
New England Institute for Neurology and Headache
Stamford, Connecticut 06905
United StatesSite Not Available
Michigan Headache and Neurological Institute
Ann Arbor, Michigan 48104-5131
United StatesSite Not Available
Dent Neurologic Institute - Amherst
Amherst, New York 14226
United StatesSite Not Available
Cleveland Clinic - Neurological Institute
Cleveland, Ohio 44195
United StatesSite Not Available
Thomas Jefferson University Hospital - Center City Campus
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
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