A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Completed · Phase 4 · Has a placebo group

Conditions studied: Migraine, Medication Overuse Headache

In brief

Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

Key facts

Study ID

NCT05452239

Run by

H. Lundbeck A/S

People needed

608

Starts

2022-07-01

Expected to finish

2025-03-13

Last updated by the study team

2026-01-29

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 migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
• The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has had an onset of migraine diagnosis at ≤50 years of age.

You may not qualify if…

• The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
• The participant has a diagnosis of acute or active temporomandibular disorders.
• The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, 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).
• The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
• 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

• Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS — Marrero, Louisiana, United States
• Clinvest - National Ave - Headlands - PPDS — Springfield, Missouri, United States
• Dent Neurologic Institute - Amherst — Amherst, New York, United States
• Headache Center - Montefiore Medical Center - BRANY - PPDS — The Bronx, New York, United States
• Texas Center for Drug Development, Inc — Houston, Texas, United States
• Southern Neurology — Kogarah, New South Wales, Australia
• Mater Adult Hospital — South Brisbane, Queensland, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Alfred Health — Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Danish Headache Center — Glostrup Municipality, Capital, Denmark
• Sydvestjysk Sygehus Esbjerg — Esbjerg, Denmark
• CHU de Nice — Nice, Alpes-Maritimes, France
• Assistance Publique Hopitaux de Marseille — Marseille, Bouches-du-Rhône, France
• Hôpital Pierre-Paul Riquet — Toulouse, Haute-Garonne, France
• Centre Hospitalier Annecy Genevois - Site d'Annecy — Pringy, Haute-Savoie, France
• CHRU Nantes — Saint-Herblain, Loire-Atlantique, France
• Hôpital Roger Salengro — Lille, Nord, France
• Centre Hospitalier Universitaire de Saint Etienne — Saint-Priest-en-Jarez, Pays de la Loire Region, France
• Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert — Clermont-Ferrand, Puy-de-Dôme, France
• Hospices Civils de Lyon - Hôpital Pierre Wertheimer — Bron, Rhône, France
• AP-HP - Hopital Lariboisiere — Paris, France
• Groupe Hospitalier Paris Saint Joseph — Paris, France
• Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10 — Tbilisi, Georgia
• Clinical Research of Central Florida - ClinEdge - PPDS — Winter Haven, Florida, United States

Full record on ClinicalTrials.gov

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