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

Completed · Phase 3

Conditions studied: Chronic Cluster Headache

In brief

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

Key facts

Study ID

NCT05064397

Run by

H. Lundbeck A/S

People needed

131

Starts

2021-09-17

Expected to finish

2023-06-29

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Screening Visit.
• The participant has a medical history of onset of cluster headache at ≤50 years of age.
• The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit.
• The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).

You may not qualify if…

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies [mAbs] and gepants).
• The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).
• The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, 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 or who have not been adequately treated for a minimum of 6 months prior to Screening Visit.
• The participant has attempted suicide or is, at Screening Visit, at significant risk of 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 pulmonary embolism).
• Other inclusion and exclusion criteria may apply.

Where it is running

• New England Institute for Neurology and Headache — Stamford, Connecticut, United States
• Michigan Headache and Neurological Institute — Ann Arbor, Michigan, United States
• Dent Neurologic Institute - Amherst — Amherst, New York, United States
• Cleveland Clinic - Neurological Institute — Cleveland, Ohio, United States
• Thomas Jefferson University Hospital - Center City Campus — Philadelphia, Pennsylvania, United States
• Rigshospitalet Glostrup — Glostrup Municipality, Capital Region, Denmark
• Hospitalsenhed Midt og Regionshospitalet Viborg — Viborg, Central Jutland, Denmark
• Terveystalo Ruoholahti — Helsinki, Southern Finland, Finland
• Terveystalo Turku Pulssi — Turku, Western Finland, Finland
• Hôpital Cimiez — Nice, Côte-d'Or, France
• Hôpital Roger Salengro — Lille, Nord, France
• Hôpital de la Timone — Marseille, Provence-Alpes-Côte d'Azur Region, France
• Hôpital Pierre Wertheimer — Bron, Rhône, France
• Centre Hospitalier Universitaire de Saint-Étienne — Saint-Priest-en-Jarez, Rhône, France
• Hôpital Lariboisière — Paris, Île-de-France Region, France
• Kopfschmerzzentrum Frankfurt — Frankfurt am Main, Hesse, Germany
• Charité Campus Mitte — Berlin, Germany
• Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car... — Milan, Milan, Italy
• Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana — Rome, Roma, Italy
• IRCCS Istituto Delle Scienze Neurologiche di Bologna — Bologna, Italy
• Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS — Pavia, Italy
• Ospedale Molinette - Clinica Neurologica II - Centro Cefalee — Turin, Italy
• Canisius-Wilhelmina Ziekenhuis — Nijmegen, Gelderland, Netherlands
• Brain Research Center - Amsterdam — Amsterdam, North Holland, Netherlands
• Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain

Full record on ClinicalTrials.gov

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