Eptinezumab in Participants With Episodic Cluster Headache

Completed · Phase 3 · Has a placebo group

Conditions studied: Cluster Headache, Episodic

In brief

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Key facts

Study ID

NCT04688775

Run by

H. Lundbeck A/S

People needed

231

Starts

2020-12-23

Expected to finish

2023-10-05

Last updated by the study team

2024-08-09

Who can join

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

You may qualify if…

• The participant has episodic cluster headache, as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) classification, with an adequately documented record or reliable history of eCH of at least 12 months prior to Screening Visit 1.
• The participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated.
• The participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine).
• The participant is, at Screening Visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to Screening Visit 2.
• The participant has a medical history of first symptoms of cluster headache from ≤60 years of age.

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 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 brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. 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 2 are also excluded.
• The participant is, at Screening Visit 2, at significant risk of suicide.
• The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, 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

• Mayo Clinic in Arizona - Phoenix Campus — Phoenix, Arizona, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Clinical Research Institute — Los Angeles, California, United States
• Stanford Neurosciences Health Center — Palo Alto, California, United States
• Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center — Denver, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• New England Institute for Neurology and Headache — Stamford, Connecticut, United States
• Accel Research Sites - Tampa — Tampa, Florida, United States
• Diamond Headache Clinic — Chicago, Illinois, United States
• Michigan Headache and Neurological Institute — Ann Arbor, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• The Headache Center Mississippi — Ridgeland, Mississippi, United States
• Clinvest Research — Springfield, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Dent Neurologic Institute - Amherst — Amherst, New York, United States
• New York University School of Medicine — New York, New York, United States
• Headache Wellness Center — Greensboro, North Carolina, United States
• Cleveland Clinic - Neurological Institute — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Hightower Clinical — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University Hospital - Center City Campus — Philadelphia, Pennsylvania, United States
• Mischer Neuroscience Institute — Houston, Texas, United States
• Froedtert and Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Universitair Ziekenhuis Brussel — Brussels, Brussels Capital, Belgium
• Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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