A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.

Key facts

Study ID

NCT04418765

Run by

H. Lundbeck A/S

People needed

892

Starts

2020-06-01

Expected to finish

2022-09-15

Last updated by the study team

2023-09-29

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, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
• The participant has a migraine onset of ≤50 years of age.
• The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
• The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
• For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
• For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
• The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
• The participant has a history of either previous or active use of triptans for migraine.

You may not qualify if…

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
• The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
• The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
• The participant has a diagnosis of acute or active temporomandibular disorder.
• 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), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
• The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
• Other in- and exclusion criteria may apply

Where it is running

• Sarkis Clinical Trials - Gainesville — Gainesville, Florida, United States
• Accel Research Sites - Maitland — Maitland, Florida, United States
• Michigan Headache and Neurological Institute — Ann Arbor, Michigan, United States
• Clinical Research Institute Inc. - Minneapolis — Minneapolis, Minnesota, United States
• Albuqerque Clinical Trials — Albuquerque, New Mexico, United States
• Dent Neurologic Institute - Amherst — Amherst, New York, United States
• Integrative Clinical Trials — Brooklyn, New York, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights — Dayton, Ohio, United States
• Lynn Health Science Institute - Oklahoma City — Oklahoma City, Oklahoma, United States
• Clinical Neuroscience Solutions - Memphis — Memphis, Tennessee, United States
• Northwest Clinical Research Center (NWCRC) — Bellevue, Washington, United States
• Northwest Neurological — Spokane, Washington, United States
• Universitair Ziekenhuis Brussel — Brussels, Brussels Capital, Belgium
• Jessa Ziekenhuis - Campus Virga Jesse — Hasselt, Limburg, Belgium
• Universitair Ziekenhuis Gent — Ghent, Oost-Vlaanderen, Belgium
• Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan — Bruges, West-Vlaanderen, Belgium
• Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum — Sofia, Sofia-Grad, Bulgaria
• First Multiprofile Hospital for Active Treatment - Sofia — Sofia, Sofia-Grad, Bulgaria
• Multiprofile Hospital for Active Treatment Heart and Brain EAD — Pleven, Bulgaria
• Medical Center - Teodora EOOD — Rousse, Bulgaria
• Acibadem City Clinic Tokuda Hospital — Sofia, Bulgaria
• Medical Center Medica Plus — Veliko Tarnovo, Bulgaria
• MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance — Hradec Králové, Hradec Kralové, Czechia
• Diablo Clinical Research — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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