A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

Last updated: July 15, 2024
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

3

Condition

Migraine (Pediatric)

Chronic Pain

Migraine And Cluster Headaches

Treatment

Eptinezumab

Clinical Study ID

NCT05064397
19385A
  • Ages 18-75
  • All Genders

Study Summary

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

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

Total Participants: 131
Treatment Group(s): 1
Primary Treatment: Eptinezumab
Phase: 3
Study Start date:
September 17, 2021
Estimated Completion Date:
June 29, 2023

Study Description

The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.

Connect with a study center

  • Rigshospitalet Glostrup

    Glostrup, Hovedstaden 2600
    Denmark

    Site Not Available

  • Hospitalsenhed Midt og Regionshospitalet Viborg

    Viborg, Midtjylland 8800
    Denmark

    Site Not Available

  • Terveystalo Ruoholahti

    Helsinki, Southern Finland 00180
    Finland

    Site Not Available

  • Terveystalo Turku Pulssi

    Turku, Western Finland 20100
    Finland

    Site Not Available

  • Hôpital Cimiez

    Nice Cedex 1, Côte-d'Or 91179 - 06003
    France

    Site Not Available

  • Hôpital Roger Salengro

    Lille, Nord 59037
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille Cedex 5, Provence Alpes Cote d'Azur 13005
    France

    Site Not Available

  • Hôpital Pierre Wertheimer

    Bron, Rhône 69677
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Priest-en-Jarez, Rhône 42055
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris, Île-de-France 75010
    France

    Site Not Available

  • Kopfschmerzzentrum Frankfurt

    Frankfurt/ Main, Hessen 65929
    Germany

    Site Not Available

  • Charité Campus Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...

    Milano, Milan 20133
    Italy

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

    Rome, Roma 00163
    Italy

    Site Not Available

  • IRCCS Istituto Delle Scienze Neurologiche di Bologna

    Bologna, 40123
    Italy

    Site Not Available

  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

    Pavia, 27100
    Italy

    Site Not Available

  • Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

    Turin, 10126
    Italy

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland 6532 SZ
    Netherlands

    Site Not Available

  • Brain Research Center - Amsterdam

    Amsterdam, Noord-Holland 1081 GN
    Netherlands

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    València, 46010
    Spain

    Site Not Available

  • The Walton Centre NHS Foundation Trust

    Liverpool, England L9 7LJ
    United Kingdom

    Site Not Available

  • Walton Centre NHS Foundation Trust

    Liverpool, England L9 7LJ
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London, England SE5 9RS
    United Kingdom

    Site Not Available

  • New England Institute for Neurology and Headache

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Michigan Headache and Neurological Institute

    Ann Arbor, Michigan 48104-5131
    United States

    Site Not Available

  • Dent Neurologic Institute - Amherst

    Amherst, New York 14226
    United States

    Site Not Available

  • Cleveland Clinic - Neurological Institute

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Thomas Jefferson University Hospital - Center City Campus

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.